Z-0435-05

B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers...

Name: Z-0435-05 B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers...
Creator: Abbott Laboratories, Inc
Published: 2001-12-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2001-12-14 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of 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... on 2001-12-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0435-05
Status: Terminated
Initiated: 2001-12-14
Posted: 2005-01-26
Terminated: 2005-11-02
Recalling firm: Abbott Medical
Product: 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
Product code: LID
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.
FDA root cause: Other
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.
Quantity in commerce: 6860 units
Distribution: The B12 reagent was only distributed to foreign countries including Canada, Germany, Hong Kong, Japan, Dingapore, Australia, and New Zealand
Product codes and lots: All lots manufactured.

Product code LID

K984108Class IIAbbott Architect B12Abbott Laboratories / cleared 1999-02-03

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)