FDA Medical Device Recalls (openFDA)
Remel, Inc.: ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.
- Recall number
- Z-1373-04
- Recalling firm
- Remel, Inc.
- Product
- ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.
- Status
- Terminated
- Initiated
- 2002-07-18
- Posted
- 2004-08-17
- Terminated
- 2004-09-15
- Reason
- A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
- 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
- 83 (15-2474048, 68-2474096)
- Distribution
- US and OUS.
- Lot, serial or model codes
- 918706 918707
- 510(k) numbers
- ["K980507"]
- PMA numbers
- not on file
- Product code
- GMZ
- 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