Sekisui Diagnostics Llc: Medical Device Recall in 2012 - (Recall #: Z-1902-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 29, 2012

Date Posted: July 4, 2012

Recall Number: Z-1902-2012

Event ID: 62017

Reason for Recall:

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

Status: Terminated

Product Quantity: 1600 kits

Code Information:

Lot 41928UQ11 {exp 2013-01 -31 )

Distribution Pattern:

Illinois

Voluntary or Mandated:

Voluntary: Firm initiated