Fisher Diagnostic, A Company of Fisher Scientific LLC Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Fisher Diagnostic, A Company of Fisher Scientific LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Fisher Diagnostic, A Company of Fisher Scientific LLC is recalling Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardbo due to Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026