Recall Z-0923-2018
Abbott Laboratories, Inc · initiated December 8, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15 cuvette segments) 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.
Codes / lots: All serial numbers
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0923-2018
- Initiated
- December 8, 2017
- Posted by FDA
- January 18, 2018
- Terminated
- July 11, 2019
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 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, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyrus, Czech Republic, Dem Rep of…
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0921-2018 Class II | ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT…There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached… | 12/08/2017Terminated |
| Z-0922-2018 Class II | ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT…There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached… | 12/08/2017Terminated |