Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog N
FDA device recall Z-1625-2008 · posted 2008-05-14 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIB
- Quantity affected
- 554/2-ml packs
- Distribution
- Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K.
- Date initiated
- 2007-10-23
- Date posted
- 2008-05-14
- Date terminated
- 2008-07-16
- Location
- Lenexa, KS
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