FDA Medical Device Recalls (openFDA)
bioMerieux: MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
- Recall number
- Z-0053-05
- Recalling firm
- bioMerieux
- Product
- MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
- Status
- Terminated
- Initiated
- 2004-08-20
- Posted
- 2004-10-28
- Terminated
- 2005-06-09
- Reason
- Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
- Root cause
- Other
- Action
- Consignees were notified by letter on 8/20/2004.
- Quantity
- 1165 units
- Distribution
- Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK
- Lot, serial or model codes
- Product number 252560, Lot number 505046
- 510(k) numbers
- ["K802117"]
- PMA numbers
- not on file
- Product code
- GJA
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- 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