Abbott Laboratories MPG ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories MPG
Lot Codes / Batch Numbers
lot numbers 33079M200, 33079M201
Products Sold
lot numbers 33079M200, 33079M201
Abbott Laboratories MPG is recalling ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnost due to The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument.
Recommended Action
Per FDA guidance
Abbott affiliates in Canada, Germany and Australia were e-mailed copies of the recall letter on 3/8/06 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised that the 30-day onboard storage information is not included in the barcode for the two lots. As a result the ARCHITECT system software is unable to track how long the reagent kit has been stored onboard. The accounts were instructed to manually track the onboard storage time for the two lots, and discard the kits after 30 days of onboard storage.
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