Recalls / —
—#34336
Product
ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
- FDA product code
- MHI — Giardia Spp.
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K955157
- Affected lot / code info
- 944755
Why it was recalled
The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Remel, Inc.
- Address
- 12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- US and OUS customers.
Timeline
- Recall initiated
- 2003-12-09
- Posted by FDA
- 2004-08-17
- Terminated
- 2004-09-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #34336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.