Reported Jan 11, 2023 · Ongoing
VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid…
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 Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and
- plasma (EDTA or heparin) Catalog Number6802892
- Lot codes and dates
- UDI-DI6802892 (10758750006267)
- Lot Numbers/Exp Date
1610 24-Apr-20231621 24-Apr-20231630 08-May-20231640 08-May-20231645 08-May-20231650 29-May-20231670 06-Jun-2023
- Amount recalled
- 4,158 units
Where it was sold
- Nationwide
Why it was recalled
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
This product could cause temporary or reversible health problems — stop using it.
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