Recall Z-0011-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is
| Date | Jan 15, 2015 |
| Status | Terminated |
| 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 instrument. |
| Root cause | Device Design |
| Action | The firm, Abbott Laboratories, sent a "Product Correction" letter dated June 26, 2017 to is customers via overnight mail who had not had the Field Action Mandatory Technical Service Bulletin completed on their instrument. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Contact their representative to schedule an inspection of their cuvette segments. -If a detached segment is identified o A replacement segment will be provided at no charge. o Follow your laboratory protocol regarding previously reported patient results f |
| Quantity | 1,385 cuvette segments |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria Burkina Faso, Canada, Chile, China, Columbia, Costa Rica, Croati |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980367 | AEROSET SYSTEM Abbott Laboratories, Apr 1, 1998 |