Z-1336-04

Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box...

Name: Z-1336-04 Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box...
Creator: Fisher Diagnostic, A Company of Fisher Scientific LLC
Published: 2004-07-01
License: https://open.fda.gov/license/

Fisher Diagnostics / initiated 2004-07-01 / Terminated

FDA source

Fisher Diagnostic, A Company of Fisher Scientific LLC began a recall of Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80... on 2004-07-01. The reason FDA records is "Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1336-04
Status: Terminated
Initiated: 2004-07-01
Posted: 2004-08-11
Terminated: 2004-12-07
Recalling firm: Fisher Diagnostics
Product: Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.
Product code: GHH Fibrin Split Products
Reason for recall: Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
FDA root cause: Other
Action: The recalling firm notified consignees on 7/1/04 by letter flagged as a customer notification. The notice describes the potential for invalid control results using the speckled cards. The letter requests users to return the cards for replacement. Defective cards are described as isolated to those packaged in heat sealed cellophane type bags. The firm requests customers to return a response form with quantity needed for replacement.
Quantity in commerce: 5677 kits
Distribution: Product was sold primarily to clinical laboratories nationwide and to international distributors
Product codes and lots: Lot 660-926 exp 10/31/04 Lot 660-927 exp 09/30/04 Lot 660-928 exp 11/30/04 Lot 660-929 exp 06/30/05 Lot 660-930 exp 03/31/05

Product code GHH

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)