Z-1238-03

Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux

Name: Z-1238-03 Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux
Creator: bioMerieux
Published: 2003-07-31
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2003-07-31 / Terminated

FDA source

bioMerieux began a recall of Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux on 2003-07-31. The reason FDA records is "Complaints of prolonged clot times". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1238-03
Status: Terminated
Initiated: 2003-07-31
Posted: 2003-10-15
Terminated: 2004-05-18
Recalling firm: bioMerieux, Inc.
Product: Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux,
Product code: GJS Test, Time, Prothrombin
Reason for recall: Complaints of prolonged clot times.
FDA 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 in commerce: 689 units
Distribution: The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.
Product codes and lots: Product #259553, Lot #161642, 161643 and 161690.

Product code GJS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)