FDA recall Z-1349-2023

Product

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

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

Key facts

Status

Ongoing

Initiation date

2022-11-11

Report date

2023-04-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2023