FDA Medical Device Recalls (openFDA)
Abbott Laboratories, Inc: 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
- Recall number
- Z-0435-05
- Recalling firm
- Abbott Laboratories, Inc
- 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
- Status
- Terminated
- Initiated
- 2001-12-14
- Posted
- 2005-01-26
- Terminated
- 2005-11-02
- Reason
- 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.
- 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
- 6860 units
- Distribution
- The B12 reagent was only distributed to foreign countries including Canada, Germany, Hong Kong, Japan, Dingapore, Australia, and New Zealand
- Lot, serial or model codes
- All lots manufactured.
- 510(k) numbers
- ["K984108"]
- PMA numbers
- not on file
- Product code
- LID
- Firm FEI
- 1628664
- Firm city
- Irving
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28