Reported Mar 20, 2013 · Terminated
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement:…
Innominata dba Genbio
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: Innominata Dba Genbio · 15222 Avenue Of Science Ste A · San Diego, CA · 92128-3422
Is this the product you have?
- ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960
- Package Insert SupplementCalibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease
- Lot codes and dates
Lot #120960 (121003. 121058121002)Exp./Cad/Verw/bis: 2013-09Catalog#802-3011252712527225273Label P/N 522-0040522-0037522-0011
- Amount recalled
- 195
Where it was sold
Why it was recalled
Multiple incidents of low-reacting assay plates.
This product could cause temporary or reversible health problems — stop using it.
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