Z-0053-05

MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969

Name: Z-0053-05 MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
Creator: bioMerieux
Published: 2004-08-20
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2004-08-20 / Terminated

FDA source

bioMerieux began a recall of MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969 on 2004-08-20. The reason FDA records is "Complaints were received from the field regarding prolonged clot times, high control values and erratic results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0053-05
Status: Terminated
Initiated: 2004-08-20
Posted: 2004-10-28
Terminated: 2005-06-09
Recalling firm: bioMerieux, Inc.
Product: MDA Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
Product code: GJA Test, Thrombin Time
Reason for recall: Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
FDA root cause: Other
Action: Consignees were notified by letter on 8/20/2004.
Quantity in commerce: 1165 units
Distribution: Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK
Product codes and lots: Product number 252560, Lot number 505046

Product code GJA

K802117Class IIFibri QuikGeneral Diagnostics / cleared 1980-09-26

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)