FDA Medical Device Recalls (openFDA)
Remel, Inc.: ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
- Recall number
- Z-1374-04
- Recalling firm
- Remel, Inc.
- Product
- ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
- Status
- Terminated
- Initiated
- 2002-11-21
- Posted
- 2004-08-17
- Terminated
- 2004-09-15
- Reason
- The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates.
- Root cause
- Other
- Action
- A potential contamination was noted in the conjugate in the ProSpecT Giardia/Cryptosporidium Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
- Quantity
- 12
- Distribution
- US only
- Lot, serial or model codes
- 926230
- 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