ANTI-BORRELIA — Class II medical device recall Z-0927-2013
Terminated recall by Innominata Dba Genbio, reported 2013-03-20, distributed nationwide. Multiple incidents of low-reacting assay plates.
| Recall number | Z-0927-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Innominata Dba Genbio, San Diego, CA, United States |
| Recall initiated | 2013-02-11 |
| Classified | 2013-03-08 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 195 |
| Reason classes | potency |
| Lot numbers | 120960 |
| Model numbers | 32507, 802-3011 |
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 for recall
Multiple incidents of low-reacting assay plates.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0927-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.