Skip to content
Recall Observatory FDA recall evidence

Device product

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

Z-1349-2023

November 11, 2022

Class II

Product summary

Firm
Abbott Molecular, Inc.
Event
Event 91777
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1349-2023

Official wording

Reason: 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.

Code information: Alinity m System Serial #01015, UDI: (01)00884999048034(11)220505(21)01015(240)08N53-002; ADU Serial #AMP05139.

Distribution pattern: US Distribution to state of: PA, a government account.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.