Abbott Laboratories, Inc ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufactured by Abbot Laboratories, Irving, TX. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufactured by Abbot Laboratories, Irving, TX.
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
All serial numbers.
Products Sold
All serial numbers.
Abbott Laboratories, Inc is recalling ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufactured by due to If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
Recommended Action
Per FDA guidance
Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level.
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