Home / Recalls / Medical Devices
Innominata Dba Genbio recalls ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1
Recalled March 20, 2013 · FDA recall Z-0927-2013 · Innominata
Hazard
Multiple incidents of low-reacting assay plates. · FDA Class II
Units
195
Sold at
Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
Description
Multiple incidents of low-reacting assay plates.
Product
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-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.
Manufacturer(s)
Innominata Dba Genbio
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →