Abbott ARCHITECT Analyzer Software Issues May Cause Inaccurate Test Results
Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of diagnostic laboratory analyzers with 12 confirmed software defects that may cause inaccurate test results. No illnesses or injuries reported. Affects critical diagnostic testing for multiple analyte categories, making this a high-risk scenario.
Plain-English summary
Abbott Laboratories is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated immunoassay analyzers due to software-related defects. These laboratory instruments are used for automated diagnostic testing in clinical facilities.
Twelve software-related issues have been identified in software version 9.41 and earlier. The issues include bypassing error codes, incorrect calibration, loss of module communication resulting in wash buffer container overfilling, missing quality control flags, signal spikes, abnormal optics readings, and incorrect sample aspiration.
These defects may cause inaccurate test results with unknown bias direction and magnitude. Affected testing includes cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, and inflammatory analytes.
Facilities with affected analyzers should contact Abbott Laboratories for software updates and corrective action information.
The recalled product
- Product
- ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
- Manufacturer
- Abbott Laboratories
- Hazard
- software-defect
- calibration-error
- quality-control-failure
- inaccurate-results
Distribution
Distributed in 49 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
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