FDA Medical Device Recalls (openFDA)
Remel, Inc.: ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
- Recall number
- Z-1372-04
- Recalling firm
- Remel, Inc.
- Product
- ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
- Status
- Terminated
- Initiated
- 2002-07-15
- Posted
- 2004-08-17
- Terminated
- 2006-12-28
- Reason
- A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
- Root cause
- Other
- Action
- Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits.
- Quantity
- 382
- Distribution
- Entire lot was shipped to one customer in Russelsheim, Germany.
- Lot, serial or model codes
- Lot #910718
- 510(k) numbers
- ["K982315"]
- PMA numbers
- not on file
- Product code
- LQP
- 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