FDA Device recall Z-0749-2022

Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnos…

• FDA Device
• Class II
• ongoing
• Published 2022-03-23

On 2022-03-23 the FDA classified a Class II recall of Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnos… by Abbott Laboratories, citing software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

Read the official FDA Device notice

Product

Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

Reason

Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

Identifiers

Status history

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

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0749-2022%22

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