Chemistry analyzer control modules recalled over software that may give erroneous results
Abbott Laboratories is recalling 11,653 Alinity ci-series System Control Modules because software versions 3.6.1 and lower could lead to erroneous results for multiple analytes.
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: Scored 3 under the risk-of-harm criterion: the firm states the software could produce erroneous results for multiple analytes, and no injuries are reported.
Plain-English summary
The Alinity ci-series System Control Module, REF 03R70-01 and 03R70-20, a chemistry and immunoassay analyzer component, is being recalled by correction by Abbott Laboratories.
The reason for the recall is potential performance issues found in Alinity ci-series System software versions 3.6.1 and lower that could lead to erroneous results for multiple analytes. Abbott identified the issue during internal testing of complaint investigations.
The record lists 11,653 units carrying UDI-DI 00380740137410 and GTIN 06952999490048, covering software versions 3.6.1 and lower, with affected serial numbers listed in the enforcement record. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.
Erroneous analyte results can affect clinical decisions based on them. The enforcement record reports no injuries. Laboratories should follow Abbott's instructions.
The recalled product
- Product
- Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
- Manufacturer
- Abbott Laboratories
- Affected units
- 11,653
Distribution
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