ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
This recall has been terminated (originally issued August 17, 2004).
- Company
- Remel Inc
- Recall Initiated
- May 9, 2002
- Posted
- August 17, 2004
- Terminated
- September 15, 2004
- Recall Number
- Z-1376-04
- Quantity
- 388 kits (187 - 910717, 201 - 912101)
- Firm Location
- Lenexa, KS
- Official Source
- View on FDA website ↗
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.
Distribution
in the US
Lot / Code Info
910717 912101
Root Cause
Other
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.