Recall Z-1902-2012— Sekisui Diagnostics Llc

Name: FDA recall Z-1902-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-29

Class II · Terminated

Class II FDA medical device recall by Sekisui Diagnostics Llc, initiated 2012-05-29, terminated 2012-11-14. It names one FDA 510(k) clearance: K042330. Product: 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: Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery..

Recalling firm: Sekisui Diagnostics Llc
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Terminated: 2012-11-14
Firm location: Framingham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K042330 — ACETAMINOPHEN-SL ASSAYDiagnostic Chemicals , Ltd.·cleared 2005-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.