FDA Device recall Z-0927-2013
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960
- FDA Device
- Class II
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class II recall of ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960 by Innominata, citing multiple incidents of low-reacting assay plates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0927-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-11 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Innominata |
| Distribution | US |
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.
Reason
Multiple incidents of low-reacting assay plates.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0927-2013%22
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