Device recall
Z-0927-2013: ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960…
FDA device recall · Class II · Innominata Dba Genbio
Key facts
| Recall number (Z-number) | Z-0927-2013 |
|---|---|
| Recall event | 64348 |
| 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. |
| Product code | LSR |
| Recalling firm | Innominata Dba Genbio |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2013 |
| 510(k) numbers | K911590 |
| FEI number | 2027113 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database