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U.S. Department of Health and Human Services

Class 2 Device Recall QUANTALyser 240 EIA

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  Class 2 Device Recall QUANTALyser 240 EIA see related information
Date Initiated by Firm January 26, 2018
Create Date March 27, 2018
Recall Status1 Terminated 3 on May 22, 2018
Recall Number Z-1222-2018
Recall Event ID 79380
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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.
Code Information Serial number 4316
Recalling Firm/
Manufacturer		 Inova Diagnostics Incorporated
9900 Old Grove Rd
San Diego CA 92131-1638
For Additional Information Contact Ms. Ronda Elliott
858-586-9900 Ext. 1381
Manufacturer 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 2		 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 in Commerce 1 instrument
Distribution There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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