RecallRadar

FDA Device recall Z-0710-2022

Alinity m Integrated Reaction Units (IRU)

On 2022-03-09 the FDA classified a Class II recall of Alinity m Integrated Reaction Units (IRU) by Abbott Molecular, citing there is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0710-2022
ClassificationClass II
Statusterminated
Initiated2022-02-11
Published2022-03-09
Last updated2026-09-13 11:56 UTC
CompanyAbbott Molecular
DistributionUS

Product

Alinity m Integrated Reaction Units (IRU)

Reason

There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.

Identifiers

code_info
List Number 09N26-010, Lot Numbers/UDI: 1) 766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010 2) 770433 / (0…List Number 09N26-010, Lot Numbers/UDI: 1) 766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010 2) 770433 / (01)20884999047864(10)770433(11)210621(240)09N26-010 3) 771200 / (01)20884999047864(10)771200(11)210712(240)09N26-010 4) 771201 / (01)20884999047864(10)771201(11)210719(240)09N26-010 5) 773642 / (01)20884999047864(10)773642(11)210723(240)09N26-010

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0710-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.