Reported May 25, 2022 · Ongoing
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
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 · 1001 Us Highway 202 · Raritan, NJ · 08869-1424
Is this the product you have?
- VITROS Immunodiagnostic
- Products LH Reagent Pack Product Code1350198
- Lot codes and dates
- Until further notice, future lots will also be affected
- UDI10758750008902
- Affected Lot Number/ Expiration Date
191014-AUG-2022192019-SEP-2022193019-OCT-2022194031-OCT-2022195028-JAN-2023196031-JAN-2023
- Amount recalled
- 1575 units total: 1183 US; 392 OUS
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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