FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.
- Recall number
- Z-0781-04
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.
- Status
- Terminated
- Initiated
- 2004-03-23
- Posted
- 2004-07-20
- Terminated
- 2005-04-26
- Reason
- The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.
- Root cause
- Other
- Action
- Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.
- Quantity
- 1,987 kits
- Distribution
- Canada, Australia, Germany and Japan
- Lot, serial or model codes
- lot numbers 07747M100 and 07747M101
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NIG
- 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