FDA Medical Device Recalls (openFDA)
Biomerieux, Inc.: BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
- Recall number
- Z-0628-03
- Recalling firm
- Biomerieux, Inc.
- Product
- BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
- Status
- Terminated
- Initiated
- 2002-12-23
- Posted
- 2003-03-06
- Terminated
- 2004-01-21
- Reason
- Vial to vial variability which can result in prolonged clot times.
- Root cause
- Other
- Action
- Consignees were notified by letter via regular mail on December 23, 2002. They were advised to cease using the product, pull affected lot numbers, destroy the material and contact bioMerieux for replacement. Expanded recall 3/18/2003, consignees were notified by letter on March 19th , and March 31, 2003. Consignees were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement.
- Quantity
- 4276 kits of lot #161553, 4275 kits of lot #161580, 4279 kits of lot #161581 and 4300 kits of lot 161661. Additional 2,280 kits of lot 161662.
- Distribution
- CA, CO, FL, GA, IA, IN, MN, NC, NJ, TN, WI. Australia, Brazil, Buenos Aires, Canada, Colombia, Hong Kong, Japan, Korea, Mexico, Netherlands, Thailand and the United Kingdom. There were no government accounts involved.
- Lot, serial or model codes
- Product# 252182- Lot #161553, 161580, 161581 and 161661. Additional Catalog number: 252183, Lot number: 161662. Additional lot numbers recalled 3/19 & 31/2003: Lot #161639, 161664, 161716 and 161717. Recall expanded on 5/30/2003 to include the balance of the lot number produced under previous manufacturing practice. Product Number 252182 (6 ml), Lot number 161506; Prduct Number 252183 (20 ml), Lot Number 161503, 161504, 161554, 161582 and 161640.
- 510(k) numbers
- ["K882214"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 1039284
- 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