Abbott Laboratories, Inc ARCHITECT i2000sr Processing Module, for in vitro diagnostics; List Number 3M74-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott 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; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60 and v3.00; distributed by Abbott 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; v2.10, v2.11, v2 due to One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration optio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chem
Recommended Action
Per FDA guidance
Notification letters sent to consignees on 04/30/07. Consignees provided with work around instructions for the software glitches and asked to respond via fax using Customer Reply form acknowledging receipt, understanding and completion of correction letter. This is the short term fix pending software updates, validation,and full root cause determination.
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
PR
Page updated: Jan 10, 2026