Abbott Laboratories MPG ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
Brand
Abbott Laboratories MPG
Lot Codes / Batch Numbers
lot numbers 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100
Products Sold
lot numbers 21082M200, 22024M100, 21082M201, 22024M101, 16603M200, and 22025M100
Abbott Laboratories MPG is recalling ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 due to concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package inse. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert.
Recommended Action
Per FDA guidance
Abbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution.
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 noticePage updated: Jan 10, 2026