FDA Medical Device Recalls (openFDA)
Abbott Laboratories MPG: ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
- Recall number
- Z-0783-05
- Recalling firm
- Abbott Laboratories MPG
- Product
- ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
- Status
- Terminated
- Initiated
- 2005-03-11
- Posted
- 2005-04-28
- Terminated
- 2006-01-18
- Reason
- concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert.
- Root cause
- Other
- Action
- Abbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution.
- Quantity
- 2,521 kits
- Distribution
- Canada, Singapore, New Zealand, Germany, Hong Kong, Japan, and Australia
- Lot, serial or model codes
- lot numbers 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CGN
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- 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