Drug recall
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement…
FDA recall event 64348 · Class II · Innominata Dba Genbio
Key facts
| Event ID | 64348 |
|---|---|
| Recall numbers | Z-0927-2013 |
| Recalling firm | Innominata Dba Genbio |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Multiple incidents of low-reacting assay plates. |
| Initiation date | Feb 11, 2013 |
| Report date | Mar 20, 2013 |
| Termination date | Aug 27, 2013 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2027113 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: