ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
FDA device recall Z-1372-04 · posted 2004-08-17 · Terminated
Recall details
- Recalling firm
- Remel, Inc.
- Reason for recall
- A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
- Action taken
- Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.
- Root cause
- Other
- Status
- Terminated
- Product code
- LQP
- Quantity affected
- 382
- Distribution
- Entire lot was shipped to one customer in Russelsheim, Germany.
- Date initiated
- 2002-07-15
- Date posted
- 2004-08-17
- Date terminated
- 2006-12-28
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROSPECT CAMPYLOBACTER MICROPLATE ASSAY (K982315) | Alexon - Trend, Inc. | 1998-11-18 |