Recall archive
128 recalls · page 4 of 6
Reported Jan 4, 2017
VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product Code 6802892 - Reagent Pack,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during the…
FDA (openFDA device enforcement)
Reported Dec 28, 2016
VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) ,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand · Reason for recall — CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low…
FDA (openFDA device enforcement)
Reported Nov 2, 2016
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details · Reason for recall — Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2016
VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier…
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 confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2016
The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand — There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.
FDA (openFDA device enforcement)
Reported Aug 24, 2016
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand · Product details — A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves…
FDA (openFDA device enforcement)
Reported Aug 17, 2016
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog…
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 issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential…
FDA (openFDA device enforcement)
Reported Aug 10, 2016
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No.…
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 confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative…
FDA (openFDA device enforcement)
Reported Aug 3, 2016
VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or…
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) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the…
FDA (openFDA device enforcement)
Reported Jul 20, 2016
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand — If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2016
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry…
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 started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative,…
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 confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2016
1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain…
FDA (openFDA device enforcement)
Reported May 4, 2016
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration…
FDA (openFDA device enforcement)
Reported Apr 13, 2016
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be…
FDA (openFDA device enforcement)
Reported Mar 16, 2016
VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954.…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 20, 2016
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2015
VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No.…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand · Product details — The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2015
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is…
FDA (openFDA device enforcement)
Reported Jun 17, 2015
enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2015
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand — The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
FDA (openFDA device enforcement)
Reported May 6, 2015
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to…
FDA (openFDA device enforcement)
Reported Mar 18, 2015
VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup…
FDA (openFDA device enforcement)
Reported Jan 28, 2015
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand — Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
FDA (openFDA device enforcement)
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