Recall Z-1103-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - 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 monitori
| Date | Jul 17, 2018 |
| Status | Terminated |
| Reason | There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 3,794 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, Colomb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |