FDA Medical Device Recalls (openFDA)
Remel, Inc.: ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
- Recall number
- Z-1375-04
- Recalling firm
- Remel, Inc.
- Product
- ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
- Status
- Terminated
- Initiated
- 2003-12-09
- Posted
- 2004-08-17
- Terminated
- 2004-09-15
- Reason
- The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
- Root cause
- Other
- Action
- 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.
- Quantity
- 127 kits
- Distribution
- US and OUS customers.
- Lot, serial or model codes
- 944755
- 510(k) numbers
- ["K955157"]
- PMA numbers
- not on file
- Product code
- MHI
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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