ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There a

FDA device recall Z-0923-2018 · posted 2018-01-18 · Terminated

Recall details

Recalling firm

Abbott Laboratories, Inc

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.

Action taken

The firm, Abbott Laboratories, issued a "Product Correction" letter dated 12/8/2017 via overnight mail on 12/8/2017 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to adhere to the new instructions listed in Appendix A to avoid damaging the cuvette segments; If a cuvette segment with a detached bottom is identified, replace it before performing any additional testing on your ARCHITECT Clinical Chemistry System; If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter and retain this letter for your laboratory records. The procedures will be updated in a future version of the ARCHITECT Operations Manual. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.

Root cause

Device Design

Status

Terminated

Product code

JJE

Quantity affected

1,560 ARCHITECT c16000 Systems

Distribution

Worldwide Distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus,

Date initiated

2017-12-08

Date posted

2018-01-18

Date terminated

2019-07-11

Location

Irving, TX

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