ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
This recall has been terminated (originally issued August 17, 2004).
- Company
- Remel Inc
- Recall Initiated
- December 9, 2003
- Posted
- August 17, 2004
- Terminated
- September 15, 2004
- Recall Number
- Z-1375-04
- Quantity
- 127 kits
- Firm Location
- Lenexa, KS
- Official Source
- View on FDA website ↗
Reason for Recall
The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
Distribution
US and OUS customers.
Lot / Code Info
944755
Root Cause
Other
Action Taken
Remel contacted each customer with a letter, by mail, requesting a count of the affected lots to be returned. Product would be replaced upon customer request.
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