Recalls / —
—#34337
Product
ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
- FDA product code
- MHJ — Cryptosporidium Spp.
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K031965
- Affected lot / code info
- 910717 912101
Why it was recalled
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 (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Remel, Inc.
- Address
- 12076 Santa Fe Trail Dr (PO Box 14478, zip 66285-4478), Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- in the US
Timeline
- Recall initiated
- 2002-05-09
- Posted by FDA
- 2004-08-17
- Terminated
- 2004-09-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #34337. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.