Abbott Laboratories, Inc ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irving, TX. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20, v2.20DB, v2.60, v3.10, 3.11 and 3.12; distributed by Abbott Laboratories, Irving, TX. The Abbott ARCHITECT cSystem is designed to perform automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Brand
Abbott Laboratories, Inc
Lot Codes / Batch Numbers
Version 2.20, List #05F48-13, Part #7-201738-01, Version 2.20DB, List #05F48-14, Part #7-201738-02, Version 2.60, List #05F48-17, Part #7-203715-01, Version 3.10, List #05F48-18, Part #7-203715-02, Version 3.11, List #05F48-20, Part 7-203715-03, and Version 3.12, List #05F48-21
Products Sold
Version 2.20, List #05F48-13, Part #7-201738-01; Version 2.20DB, List #05F48-14, Part #7-201738-02; Version 2.60, List #05F48-17, Part #7-203715-01; Version 3.10, List #05F48-18, Part #7-203715-02; Version 3.11, List #05F48-20, Part 7-203715-03; and Version 3.12, List #05F48-21
Abbott Laboratories, Inc is recalling ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and 1G06-11, Affec due to Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample.
Recommended Action
Per FDA guidance
Firm notified all ARCHITECT c8000 customers with a correction letter and response form distributed on 5/23/2008. The letter provided actions the users could take until an updated software version was available. For assistance, contact Abbott at 1-877-4ABBOTT.
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