Class 2 Device Recall IMx Folate Reagent Pack

• Date Initiated by Firm: November 23, 2003
• Date Posted: January 06, 2004
• Recall Status: Terminated on July 22, 2004
• Recall Number: Z-0293-04
• Recall Event ID: 27835
• 510(K)Number: K9436912
• Product Classification: unknown device name - Product Code CGN--
• 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
• Code Information: all lots
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD/GPRD; 100/200 Abbott Park Road; Abbott Park IL 60064
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.