Recall Z-1624-2008 ยท LIB Device, General Purpose, Microbiology, Diagnostic
Remel Inc
Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Remel, Lenexa, KS 66215
| Date | May 14, 2008 (initiated Oct 23, 2007) |
| Status | Terminated |
| Reason | Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions. |
| Root cause | Other |
| Action | Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641. |
| Quantity | 500/1-ml packs |
| Distribution | Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.