Recall archive
128 recalls · page 5 of 6
Reported Jan 21, 2015
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2014
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
FDA (openFDA device enforcement)
Reported Oct 22, 2014
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details · Reason for recall — Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2014
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details · Reason for recall — Ortho Clinical Diagnostics identified a potential for biased results to be generated when using VITROS PHYT Slides, Lot 2613-0150-4913. Some…
FDA (openFDA device enforcement)
Reported Oct 1, 2014
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to…
FDA (openFDA device enforcement)
Reported Aug 20, 2014
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2014
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details · Reason for recall — Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2014
VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2014
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2014
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 ---…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details · Reason for recall — Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to…
FDA (openFDA device enforcement)
Reported May 28, 2014
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
FDA (openFDA device enforcement)
Reported May 7, 2014
VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details · Reason for recall — Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Protein (CRP) results only to be generated when using…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2014
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II…
FDA (openFDA device enforcement)
Reported Apr 23, 2014
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
FDA (openFDA device enforcement)
Reported Mar 26, 2014
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to…
FDA (openFDA device enforcement)
Reported Mar 19, 2014
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand · Product details · Reason for recall — Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used…
FDA (openFDA device enforcement)
Reported Mar 5, 2014
VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details · Reason for recall — Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2014
enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details · Reason for recall — Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2014
VITROS Chemistry Products COCM Reagent
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — Inaccurate quality control results.
FDA (openFDA device enforcement)
Reported Jan 1, 2014
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Reason for recall — Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs…
FDA (openFDA device enforcement)
Reported Dec 25, 2013
VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Reason for recall — Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due…
FDA (openFDA device enforcement)
Reported Nov 27, 2013
VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Reason for recall — Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
36 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 21, 2013
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Reason for recall — Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
FDA (openFDA device enforcement)
Reported Jul 10, 2013
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring…
4 more products in this recall
FDA (openFDA device enforcement)
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