Reported Dec 26, 2012 · Terminated
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of…
Beckman Coulter 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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
- Lot codes and dates
- Lots
220438122157118299113689109784022519014099011895008546916872
- Lots
- Amount recalled
- 14409
Where it was sold
Why it was recalled
Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif
This product could cause temporary or reversible health problems — stop using it.
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