Recall archive
128 recalls · page 3 of 6
Reported Jul 10, 2019
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2019
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
FDA (openFDA device enforcement)
Reported May 15, 2019
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2019
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to…
FDA (openFDA device enforcement)
Reported Mar 20, 2019
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
FDA (openFDA device enforcement)
Reported Feb 27, 2019
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — Negative bias results when using VITROS VALP Reagent, GEN 25.
FDA (openFDA device enforcement)
Reported Jan 9, 2019
VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2018
VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2018
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
FDA (openFDA device enforcement)
Reported Nov 14, 2018
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 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 — The reagent pack exhibits the potential for an increased frequency of calibration failures.
FDA (openFDA device enforcement)
Reported Oct 17, 2018
VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 10, 2018
VITROS Sodium Slides, Catalog # 837 9034
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — Potential for positively biased results
FDA (openFDA device enforcement)
Reported Sep 26, 2018
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) -…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand · Product details — The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 19, 2018
VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 11, 2018
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and…
FDA (openFDA device enforcement)
Reported Mar 14, 2018
VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 3, 2018
VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples.…
FDA (openFDA device enforcement)
Reported Dec 20, 2017
enGen Track System with TCAutomation Software Version 4.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended…
FDA (openFDA device enforcement)
Reported May 24, 2017
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Reason for recall — Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may…
FDA (openFDA device enforcement)
Reported May 3, 2017
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background…
FDA (openFDA device enforcement)
Reported Mar 22, 2017
VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product details — Intermittent imprecision in results generated using two specific lots of VITROS Li Slides.
FDA (openFDA device enforcement)
Reported Feb 15, 2017
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2017
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand · Product · Product details — There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at…
FDA (openFDA device enforcement)
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