Abbott Laboratories HPD/ADD/GPRD 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
List 6C12Y: lots 06537M100Y, 09888M100Y, 06537M101Y, 05081M100Y, lots06537M100 and 09888M100, List 6C12-25 (100 tests), lots 06537M101and 05081M100, List 6C12-30 (4 x 500 tests), lots 07465M300 and 10587M200.
Products Sold
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.
Abbott Laboratories HPD/ADD/GPRD is recalling ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles co due to The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
Recommended Action
Per FDA guidance
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.
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