Reported Jun 1, 2016 · Terminated
1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320,…
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 · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Lot Numbers: 1410, 1420, 1430 (With Expiry Date 17-Jun-2016) 2 Lot Number: 1440 (With Expiry Date 15-Aug-2016 3 Lot Numbers: 1450, 1460, 1470 (With Expiry Date 17-Aug-2016) and 4 Lot Number 1480 distributed only outside of U.S. (With Expiry Date 30-Sept-2016) - Amount recalled
- 14,780 pieces
Where it was sold
- Nationwide
Why it was recalled
When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).
This product could cause temporary or reversible health problems — stop using it.
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