FDA Device

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.

Hazard

Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.

What You Should Do

Remedy

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.

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Products

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.
Brand
Sekisui Diagnostics Llc
UPC
Lot 41928UQ11 {exp 2013-01 -31 )

Units Affected

1600 kits

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