FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA
- Recall number
- Z-0293-04
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA
- Status
- Terminated
- Initiated
- 2003-11-23
- Posted
- 2004-01-06
- Terminated
- 2004-07-22
- Reason
- Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing.
- Root cause
- Other
- Action
- Abbott notified their international affiliates via e-mail on 11/23/03. Important Product Information letters dated 11/24/03 will be sent to the end users by the affiliates, informing them of the possible methotrexate carryover to subsequent samples and falsely elevated folate values.
- Quantity
- 3,475 packs
- Distribution
- There was no U.S. distribution. The product was internationally distributed through Abbott subsidiaries in Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England and Australia.
- Lot, serial or model codes
- all lots
- 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