FDA Medical Device Recalls (openFDA)
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 number
- Z-1336-04
- Recalling firm
- Fisher Diagnostic, A Company of Fisher Scientific LLC
- 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.
- Status
- Terminated
- Initiated
- 2004-07-01
- Posted
- 2004-08-11
- Terminated
- 2004-12-07
- Reason
- Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
- 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
- 5677 kits
- Distribution
- Product was sold primarily to clinical laboratories nationwide and to international distributors
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GHH
- Firm FEI
- 1181121
- Firm city
- Middletown
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28