Recall Z-1376-04 ยท MHJ Cryptosporidium Spp.
Remel, Inc.
ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
| Date | Aug 17, 2004 (initiated May 9, 2002) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 388 kits (187 - 910717, 201 - 912101) |
| Distribution | in the US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 Remel, Inc., Nov 14, 2003 |