MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
FDA Recall Z-1902-2012 · Posted 2012-06-27
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Recalling FirmSekisui Diagnostics Llc
Recall StatusTerminated
Product CodeLDP
Date Initiated2012-05-29
Date Terminated2012-11-14
Product Quantity1600 kits
Reason for Recall
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
Firm Action
Sekisui Diagnostics Llc sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop using the affected product and to destroy any remaining inventory. A Confirmation of Notification Form was attached for customers to complete and return via fax to 902-628-6504. Contact the firm at 902-628-0984 for questions regarding this notice.
Root Cause
Storage
Distribution Pattern
Illinois
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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