FDA Medical Device Recalls (openFDA)
BIOMERIEUX, INC.: Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704
- Recall number
- Z-0843-05
- Recalling firm
- BIOMERIEUX, INC.
- Product
- Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704
- Status
- Terminated
- Initiated
- 2005-03-07
- Posted
- 2005-05-18
- Terminated
- 2006-10-16
- Reason
- The ISI labeling for Simplastin HTF on the Coag-a-Mate MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.
- Root cause
- Other
- Action
- Consignees were notified by letter on/about March 7, 2005.
- Quantity
- 19748 kits
- Distribution
- Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand
- Lot, serial or model codes
- Product numbers 259846, 259847, Lot numbers: 161849, 161800 and 161798. Recall Expanded (03/23/2005) to include these additional lot numbers: 161655, 161710, 161741, 161738, 161742, 1621739, 161743, 161740, 161764, 161763, 161797 and 161799.
- 510(k) numbers
- K974566
- PMA numbers
- not on file
- Product code
- GJS
- 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