Recall Z-0921-2018— Abbott Laboratories, Inc

Name: FDA recall Z-0921-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-08

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2017-12-08, terminated 2019-07-11. It names one FDA 510(k) clearance: K980367. Product: ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.. Reason: There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument..

Recalling firm: Abbott Laboratories, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-12-08
Terminated: 2019-07-11
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K980367 — AEROSET SYSTEMAbbott Laboratories·cleared 1998-04-01

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

ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the system and are racks that sit in the reaction carousel and hold cuvettes.

Reason for recall

There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.

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