CLASS III ONGOING Device recall · Reported 25 Jan 2023 · FDA Enforcement Report
Alinity Reaction Vessels recalled by Abbott Laboratories
Abbott Laboratories is recalling Alinity Reaction Vessels, distributed in 11 states. The recall was initiated on 24 Nov 2022 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0958-2023
- FDA event ID
- 91303
- Recalling firm
- Abbott Laboratories, Irving, TX
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 24 Nov 2022
- FDA classified
- 17 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Nov 2022 | Recall initiated by company | |
| 17 Jan 2023 | Classified by FDA | +54 days |
| 25 Jan 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reaction vessels may contain a potential contaminant that could affect their optical performance.
Product as listed by the FDA
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Where it was distributed
US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
IllinoisMinnesotaMissouriNorth CarolinaNorth DakotaNew JerseyNew YorkOklahomaSouth CarolinaTexasWest Virginia
Questions about this recall
Why was it recalled?
Reaction vessels may contain a potential contaminant that could affect their optical performance.
Which lots are affected?
UDI-DI/Lots: 00380740129026/000586790 and 000586879
Where was it sold?
US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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