Z-1233-2007

MULTIGENT Acetaminophen, List Number 2K99-20

Name: Z-1233-2007 MULTIGENT Acetaminophen, List Number 2K99-20
Creator: Abbott Laboratories Inc.
Published: 2007-06-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-06-01 / Terminated

FDA source

Abbott Laboratories Inc. began a recall of MULTIGENT Acetaminophen, List Number 2K99-20 on 2007-06-01. The reason FDA records is "Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1233-2007
Status: Terminated
Initiated: 2007-06-01
Posted: 2007-09-18
Terminated: 2012-04-05
Recalling firm: Abbott Medical
Product: MULTIGENT Acetaminophen, List Number 2K99-20
Product code: LDP Colorimetry, Acetaminophen
Reason for recall: Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.
FDA root cause: Other
Action: The firm initiated the recall on 06/01/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions for modification to the SmartWash feature in the Lipase Assay Configuration in order to prevent Acetaminophen from contaminating Lipase.
Quantity in commerce: 342
Distribution: Worldwide, including USA, Australia, Brazil, Canada, Chile, El Salvador, Dominican Republic, Ecuador, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Thailand, and Venezuela.
Product codes and lots: List Number 2K99-20; Control Numbers: 30455UQ11 & 31046UQ02

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)