Z-0843-05

Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704

Name: Z-0843-05 Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704
Creator: Biomerieux, Inc.
Published: 2005-03-07
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2005-03-07 / Terminated / root cause: labeling and UDI

FDA source

BIOMERIEUX, INC. began a recall of Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704 on 2005-03-07. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0843-05
Status: Terminated
Initiated: 2005-03-07
Posted: 2005-05-18
Terminated: 2006-10-16
Recalling firm: bioMerieux, Inc.
Product: Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704
Product code: GJS Test, Time, Prothrombin
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter on/about March 7, 2005.
Quantity in commerce: 19748 kits
Distribution: Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand
Product codes and lots: 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.

Product code GJS

K974566Class IIMda Simplastin HtfOrganon Teknika Corp. / cleared 1998-02-24

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)