Home / Recalls / Sekisui Diagnostics Llc / Z-1902-2012

Z-1902-2012 Class II Terminated

Recalled by Sekisui Diagnostics Llc — Framingham, MA

Recall Details

Product Type
Devices
Report Date
July 4, 2012
Initiation Date
May 29, 2012
Termination Date
November 14, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1600 kits

Product Description

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.

Reason for Recall

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

Distribution Pattern

Illinois

Code Information

Lot 41928UQ11 {exp 2013-01 -31 )

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