Recall Z-1221-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Inova Diagnostics Incorporated
QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
| Date | Jan 26, 2018 |
| Status | Terminated |
| Reason | The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument. |
| Root cause | Nonconforming Material/Component |
| Action | The letters were issued via email on January 26, 2018, informing the consignee of the issue and the actions to be taken. The response forms were requested to be completed and returned by February 23, 2018, indicating receipt of the notification and confirmation that the power supply has been replaced. The firm reported on February 23, 2018 that responses have been received from both consignees. For further questions, please call (858) 586-9900 x 1381. |
| Quantity | 1 instrument |
| Distribution | There was no U.S. distribution. Distribution was made to Panama and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.