Recall Z-1624-2008
Remel Inc · initiated October 23, 2007
Product
Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Remel, Lenexa, KS 66215
Codes / lots: Lot 518113
Reason for recall
Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1624-2008
- Initiated
- October 23, 2007
- Posted by FDA
- May 14, 2008
- Terminated
- July 16, 2008
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Quantity
- 500/1-ml packs
- Distribution
- Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K.
- Recalling firm
- Remel Inc, Lenexa, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1625-2008 | Remel RapID Inoculation Fluid, Microorganism differentiation and identification device…Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit… | 10/23/2007Terminated |