Recall Z-1102-2019
Abbott Laboratories, Inc · initiated July 17, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
Codes / lots: All serial numbers
Reason for recall
There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.
FDA-determined cause: Software design
Action taken
Recall letters were issued in the U.S. 7/17/2018 via FedEx overnight mail notifying the consignee of the issue, patient impact, and necessary actions to take. Globally, primary methods of issuance were via mail, telephone, and email.
Details
- Recall number
- Z-1102-2019
- Initiated
- July 17, 2018
- Terminated
- September 23, 2020
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 3,675 instruments
- Distribution
- Worldwide distribution - US Nationwide and countries Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Burkina FASO, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Democratic Rep. of Congo, Denmark…
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1103-2019 Class II | Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott…There is a potential to generate incorrect results on the instrument if particular error codes are not… | 07/17/2018Terminated |
| Z-1104-2019 Class II | Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott…There is a potential to generate incorrect results on the instrument if particular error codes are not… | 07/17/2018Terminated |