Abbott Alinity m Diagnostic System Recalled for Incorrect Optical Calibration
Abbott Molecular is recalling the Alinity m System due to incorrect optical calibration. The affected unit (Serial Number 00654) was distributed to Italy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II FDA recall with no reported illnesses or injuries. The optical calibration error represents a risk-of-harm situation in a diagnostic medical device, but without reported adverse events, the score is 3 per the rubric.
Plain-English summary
Abbott Molecular, Inc. is recalling the Alinity m System, Reference 08N53-002, an in vitro diagnostic device. The recall is due to incorrect optical calibration of the device.
The affected unit, identified by Serial Number 00654, was distributed exclusively to Italy. Incorrect optical calibration may result in inaccurate diagnostic test results from the device.
This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
- Manufacturer
- Abbott Molecular, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number 00654
Distribution
Distribution scope not specified by the agency.
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