Z-1902-2012Class II

MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the...

Name: Z-1902-2012 MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the...
Creator: Sekisui Diagnostics Llc
Published: 2012-05-29
License: https://open.fda.gov/license/

Sekisui Diagnostics, LLC / initiated 2012-05-29 / Terminated / root cause: manufacturing process

FDA source

Sekisui Diagnostics Llc began a recall of MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum... on 2012-05-29. FDA classified it as Class II and gives the reason as "Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1902-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-06-27
Terminated: 2012-11-14
Recalling firm: Sekisui Diagnostics, LLC
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.
Product code: LDP Colorimetry, Acetaminophen
Reason for recall: Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
Root cause tag: manufacturing process
FDA root cause: Storage
Action: 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.
Quantity in commerce: 1600 kits
Distribution: Illinois
Product codes and lots: Lot 41928UQ11 {exp 2013-01 -31 )

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1902-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1902-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-27

Product code LDP

K042330Class IIAcetaminophen-Sl AssayDiagnostic Chemicals , Ltd. / cleared 2005-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)