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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm September 03, 2004
Date Posted September 30, 2004
Recall Status1 Terminated 3 on May 03, 2005
Recall Number Z-1496-04
Recall Event ID 30004
510(K)Number k854079  
Product Classification Test, Sickle Cell - Product Code GHM
Product Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
Code Information Lot 250-403 and 250-404, EXP 4/30/2006
Recalling Firm/
Manufacturer		 Fisher Diagnostic, A Company of Fisher Scientific LLC
8365 Valley Pike
Middletown VA 22645-1905
For Additional Information Contact Technical Support
800-528-0494
Manufacturer Reason
for Recall		 Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
FDA Determined
Cause 2		 Other
Action The firm ceased distribution on 8/24/04 and initiated recall by certified letter dated 9/3/04, which was flagged as 'customer recall notification'. The notice advised of the defective vials and requested users to return response form with the numbers of kits to be returned for replacement.
Quantity in Commerce 604 kits
Distribution Product was distributed through the manufacturer''s affiliate distribution company to 228 end users nationwide.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = GHM and Original Applicant = PACIFIC HEMOSTASIS
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