Device 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.
Z-0927-2013
Product summary
- Event
- Event 64348
- Status
- Terminated
- Classification
- Class II
- Quantity
- 195
- Official record key
device-enforcement:Z-0927-2013
Official wording
Reason: Multiple incidents of low-reacting assay plates.
Code information: Lot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011
Distribution pattern: Nationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
Derived failure modes
-
Unknown
Multiple incidents of low-reacting assay plates.