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Terminated

B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas

FDA Recall Z-0435-05 · Posted 2005-01-26

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeLID
Date Initiated2001-12-14
Date Terminated2005-11-02
Product Quantity6860 units

Reason for Recall

Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted.

Firm Action

The firm initiated the recall via letter on December 14 and 16, 2004 directing consignees to perform the two tests on different machines or to contact the customer service representative in the event the consignee only has one machine.

Root Cause

Other

Distribution Pattern

The B12 reagent was only distributed to foreign countries including Canada, Germany, Hong Kong, Japan, Dingapore, Australia, and New Zealand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984108ABBOTT ARCHITECT B12Abbott Laboratories · 1999-02-03

Official Source

View FDA Recall →

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

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