IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (
FDA device recall Z-0293-04 · posted 2004-01-06 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGN
- Quantity affected
- 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.
- Date initiated
- 2003-11-23
- Date posted
- 2004-01-06
- Date terminated
- 2004-07-22
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.