ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25, 6C12-30); 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-0364-04
- Quantity
- 2,141 kits
- 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 6C12Y: lots 06537M100Y, 09888M100Y, 06537M101Y, 05081M100Y, 07465M300Y and 10587M200Y. These diluent lots were packaged in the following reagent kit lots: List 6C12-20 (4 x 100 tests), lots06537M100 and 09888M100; List 6C12-25 (100 tests), lots 06537M101and 05081M100; List 6C12-30 (4 x 500 tests), lots 07465M300 and 10587M200.
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.