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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
all lots
Products Sold
all lots
Abbott Laboratories HPD/ADD/GPRD is recalling IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells due to Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026