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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJuly 01, 2004
Date PostedAugust 11, 2004
Recall Status1 Terminated 3 on December 07, 2004
Recall NumberZ-1336-04
Recall Event ID 29573
Product Classification Fibrin Split Products - Product Code GHH
ProductPacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests.
Code Information 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
FEI Number 1181121
Recalling Firm/
Manufacturer		 Fisher Diagnostic, A Company of Fisher Scientific LLC
8365 Valley Pike
Middletown VA 22645-1905
For Additional Information ContactFisher Technical Support staff
800-528-0494
Manufacturer Reason
for Recall		Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce5677 kits
DistributionProduct was sold primarily to clinical laboratories nationwide and to international distributors
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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