Recall Z-1222-2018
Inova Diagnostics Incorporated · initiated January 26, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
QUANTA-Lyser 240 EIA, Part #GS0241. 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.
Codes / lots: Serial number 4316
Reason for recall
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1222-2018
- Initiated
- January 26, 2018
- Terminated
- May 22, 2018
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 1 instrument
- Distribution
- There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
- Recalling firm
- Inova Diagnostics Incorporated, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1221-2018 Class II | QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated…The device power supply was not manufactured according to specification which can result in the loss of the… | 01/26/2018Terminated |