Recalls / —

—#197415

Product

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

FDA product code

DHA — System, Test, Human Chorionic Gonadotropin

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K170317

Affected lot / code info

UDI-DI/Lots: 00380740129026/000586790 and 000586879

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

On 11/24/22, the recalling firm phoned customers and informed them of the recall using a phone script. On the same day, the phone call was followed by an email that restated the information in the phone script and included a Customer Reply form. Customers were asked to discontinue use and destroy the impacted inventory according to their laboratory procedures. If customers forwarded the product to other laboratories, they were asked to inform them of this Product Recall and complete and return the Customer Reply form, which can be returned to PMS@abbott.com. The reply form asked customers to record the number of boxes destroyed. If you have any questions, contact QA Manager, Post Market Surveillance at 224-668-0343 or email: suchin.song@abbott.com.

Recalling firm

Firm

Abbott Laboratories

Address

1915 Hurd Dr, Irving, Texas 75038

Distribution

Distribution pattern

US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV

Timeline

Recall initiated

2022-11-24

Posted by FDA

2023-01-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197415. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.