ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
FDA device recall Z-1374-04 · posted 2004-08-17 · Terminated
Recall details
- Recalling firm
- Remel, Inc.
- Reason for recall
- The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates.
- Action taken
- A potential contamination was noted in the conjugate in the ProSpecT Giardia/Cryptosporidium Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHI
- Quantity affected
- 12
- Distribution
- US only
- Date initiated
- 2002-11-21
- Date posted
- 2004-08-17
- Date terminated
- 2004-09-15
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY (K955157) | Alexon Biomedical, Inc. | 1996-02-09 |