Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing m
FDA device recall Z-1336-04 · posted 2004-08-11 · Terminated
Recall details
- Recalling firm
- Fisher Diagnostic, A Company of Fisher Scientific LLC
- Reason for recall
- Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GHH
- Quantity affected
- 5677 kits
- Distribution
- Product was sold primarily to clinical laboratories nationwide and to international distributors
- Date initiated
- 2004-07-01
- Date posted
- 2004-08-11
- Date terminated
- 2004-12-07
- Location
- Middletown, VA
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