IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx Folate Mode 1 Calibrator 3.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- December 16, 2003
- Posted
- July 20, 2004
- Terminated
- July 20, 2004
- Recall Number
- Z-0370-04
- Quantity
- 51 packs
- Firm Location
- Abbott Park, IL
Reason for Recall
The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
Distribution
There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay, United Kingdom, Venezuela, Dominican Republic, Argentina and Curacao.
Lot / Code Info
List 2220-40, lots 02181M200, 04441M300, 06371M200
Root Cause
Other
Action Taken
Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx.