Z-0628-03

BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704

Name: Z-0628-03 BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
Creator: Biomerieux, Inc.
Published: 2002-12-23
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2002-12-23 / Terminated

FDA source

Biomerieux, Inc. began a recall of BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704 on 2002-12-23. The reason FDA records is "Vial to vial variability which can result in prolonged clot times". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0628-03
Status: Terminated
Initiated: 2002-12-23
Posted: 2003-03-06
Terminated: 2004-01-21
Recalling firm: bioMerieux, Inc.
Product: BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
Product code: GJS Test, Time, Prothrombin
Reason for recall: Vial to vial variability which can result in prolonged clot times.
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code GJS

K882214Class IISimplastin Excel SOrganon Teknika Corp. / cleared 1988-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)