Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations.
FDA Recall Z-1496-04 · Posted 2004-09-30
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Recalling FirmFisher Diagnostic, A Company of Fisher Scientific LLC
Recall StatusTerminated
Product CodeGHM
Date Initiated2004-09-03
Date Terminated2005-05-03
Product Quantity604 kits
Reason for Recall
Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed through the manufacturer''s affiliate distribution company to 228 end users nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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