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
This recall has been terminated (originally issued January 6, 2004).
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- November 23, 2003
- Posted
- January 6, 2004
- Terminated
- July 22, 2004
- Recall Number
- Z-0293-04
- Quantity
- 3,475 packs
- Firm Location
- Abbott Park, IL
- Official Source
- View on FDA website ↗
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.
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 / Code Info
all lots
Root Cause
Other
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.