Abbott Alinity m System Recall: Missing Components and Improper Calibration
Abbott Molecular recalled one Alinity m System diagnostic unit installed without required plunger assemblies and returned to service without proper calibration. This could result in delayed or incorrect test results.
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: FDA Class II device recall with no reported illnesses, injuries, or actual diagnostic errors. The hazard involves missing equipment components and incomplete calibration that could cause delayed or incorrect test results, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Molecular, Inc. is recalling one Alinity m System diagnostic instrument (Serial #01015, REF 08N53-002) that was distributed to a government laboratory account in Pennsylvania. During inspection, the unit's Amplification Detection Unit was found to have missing plunger assemblies in the clamp bar.
After correcting the component issue, the instrument was returned to operational use without completing proper calibration. This incomplete commissioning creates a potential for delayed test results and incorrect diagnostic findings, which could affect the accuracy of laboratory testing performed on the device.
The FDA has classified this as a Class II recall. Facilities using this equipment should verify that the device has been properly calibrated and all required components are installed and functioning correctly before resuming clinical testing.
The recalled product
- Product
- Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
- 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 (3)
- Alinity m System Serial #01015
- UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002
- ADU Serial #AMP05139.
Distribution
Distributed in 1 state:
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