FDA Medical Device Recalls (openFDA)
bioMerieux: Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux
- Recall number
- Z-1238-03
- Recalling firm
- bioMerieux
- Product
- Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux,
- Status
- Terminated
- Initiated
- 2003-07-31
- Posted
- 2003-10-15
- Terminated
- 2004-05-18
- Reason
- Complaints of prolonged clot times.
- Root cause
- Other
- Action
- Consignees were notified via letter on July 31, 2003. The were advised to check remaining inventory and destroy any remaining material of the affected lot numbers. A Customer Response form was attached.
- Quantity
- 689 units
- Distribution
- The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.
- Lot, serial or model codes
- Product #259553, Lot #161642, 161643 and 161690.
- 510(k) numbers
- not on file
- 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