Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay Recalled by Sekisui Diagnostics Llc Due to Discoloration of the acetaminophen enzyme reagent (R1), generates...

Date: May 29, 2012
Company: Sekisui Diagnostics Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sekisui Diagnostics Llc directly.

Affected 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.

Quantity: 1600 kits

Why Was This Recalled?

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

Where Was This Sold?

Illinois

About Sekisui Diagnostics Llc

Sekisui Diagnostics Llc has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report