San Diego, CA, United States
Inova Diagnostics Incorporated recalls
1 recall recorded since 2018, most recently on 26 January 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 January 2018
- Terminated
- 22 May 2018
- Reason
- The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
- Distribution
- There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1222-2018, Z-1221-2018
- 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, rea
- 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, rea
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.