Recall Z-0958-2023— Abbott Laboratories

Name: FDA recall Z-0958-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-24

Class III · Ongoing

Class III FDA medical device recall by Abbott Laboratories, initiated 2022-11-24. It names one FDA 510(k) clearance: K170317. Product: Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels. Reason: Reaction vessels may contain a potential contaminant that could affect their optical performance..

Recalling firm: Abbott Laboratories
Classification: Class III
Status: Ongoing
Initiated: 2022-11-24
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K170317 — Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories·cleared 2017-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Reason for recall

Reaction vessels may contain a potential contaminant that could affect their optical performance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.