ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
FDA device recall Z-1376-04 · posted 2004-08-17 · Terminated
Recall details
- Recalling firm
- Remel, Inc.
- Reason for recall
- A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run. Quality control testing indicates the other reagents in these kits are performing as intended.
- Action taken
- A potential stability problem has been identified with the positive control in the ProSpecT CryptoSporidium Microplate Assay. The positive control may not perform as intended through its expiration date and may invalidate an otherwise acceptable run.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHJ
- Quantity affected
- 388 kits (187 - 910717, 201 - 912101)
- Distribution
- in the US
- Date initiated
- 2002-05-09
- Date posted
- 2004-08-17
- Date terminated
- 2004-09-15
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (K031965) | Remel, Inc. | 2003-11-14 |