Reported Mar 31, 2021 · Terminated
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1…
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600
- Integrated Systems Product Code1204668
- Impacted ProductsA. VITROS
- Chemistry Products TIBC Kit Product No7541 (UDI 8750005178) All current and new lots B. VITROS
- Chemistry Products Fe Slides Product No1924547 90
- Slides (UDI 10758750000289) Product No1515808 300
- slides (UDI 10758750009244) Product No6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots
- Lot codes and dates
- Lot Numbers0449 (exp. 28-Aug-2021) 0459 (exp. 10-Feb-2022) 0460 (exp. 01-Oct-2022)
- UDI(10758750008537)
- Amount recalled
- 7546 US and 15280 OUS kits
Where it was sold
- Nationwide
Why it was recalled
Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approximately 80 ug/dL lower across the measuring range than other available GENS of VITROS Fe Slides (GENs 22-25).
This product could cause temporary or reversible health problems — stop using it.
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