Z-1349-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 12, 2023
- Initiation Date
- November 11, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Reason for Recall
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
Distribution Pattern
US Distribution to state of: PA, a government account.
Code Information
Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.