FDA Medical Device Recalls (openFDA)
Remel, Inc.: ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
- Recall number
- Z-1376-04
- Recalling firm
- Remel, Inc.
- Product
- ProSpecT Cryptosporidium Microplate Assay. Catalog #2454096.
- Status
- Terminated
- Initiated
- 2002-05-09
- Posted
- 2004-08-17
- Terminated
- 2004-09-15
- 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
- Lot, serial or model codes
- 910717 912101
- 510(k) numbers
- ["K031965"]
- PMA numbers
- not on file
- Product code
- MHJ
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28