Reported May 22, 2019 · Terminated
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level…
Abbott GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Gmbh & Co. KG · Max-Planck-Ring 2 · Wiesbaden · N/A
Is this the product you have?
- Abbott Alinity ci-series System Control Module software version 2.5.1
- LN 3R70-01 with the following hardwareLevel Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02
- Product UsageThe Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. The Alinity c (LN 03R67 01) processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes)
- Lot codes and dates
Alinity ci series System Control ModuleLN 3R70 01 Level SensorBulk SolutionLN 04S68 01 Accessory kitAlinity iLN 03R66 01LN 03R66 02 Accessory kitAlinity cLN 03R69 01LN03R69 02
- Amount recalled
- 1557
Where it was sold
Why it was recalled
Potential performance issues in the Alinity-ci software version 2.5.1
This product could cause temporary or reversible health problems — stop using it.
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