Class 3 Device Recall

• Date Initiated by Firm: September 03, 2004
• Date Posted: September 30, 2004
• Recall Status: Terminated 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
• FEI Number: 1181121
• 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: 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