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.
FDA Recall Z-1222-2018 · Posted None
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Recalling FirmInova Diagnostics Incorporated
Recall StatusTerminated
Product CodeJJE
Date Initiated2018-01-26
Date Terminated2018-05-22
Product Quantity1 instrument
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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