Reported Jul 19, 2023 · Ongoing
VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20-…
Ortho-Clinical Diagnostics
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 · 1000 Lee Rd · Rochester, NY · 14606-4250
Is this the product you have?
- VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM
- Product Code6801704
- Lot codes and dates
- UDI-DI10758750006687
- Lot Code2022 Exp
- Date06-Sept-2023
- Amount recalled
- 2400 units
Where it was sold
- Nationwide
Why it was recalled
Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
This product could cause temporary or reversible health problems — stop using it.
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