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Terminated

MULTIGENT Acetaminophen, List Number 2K99-20

FDA Recall Z-1233-2007 · Posted 2007-09-18

Recalling FirmAbbott Laboratories Inc.
Recall StatusTerminated
Product CodeLDP
Date Initiated2007-06-01
Date Terminated2012-04-05
Product Quantity342

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042330ACETAMINOPHEN-SL ASSAYDiagnostic Chemicals , Ltd. · 2005-01-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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