Inova Diagnostics Recalls QUANTA-Lyser 240 EIA Due to Power Supply Defect
Inova Diagnostics is recalling one QUANTA-Lyser 240 EIA instrument because a defective power supply may cause loss of protective grounding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of protective grounding) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Inova Diagnostics Incorporated is recalling one unit of the QUANTA-Lyser 240 EIA, Part #GS0241, serial number 4316. The device 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.
The recall was initiated because the device power supply was not manufactured according to specification. This defect can result in the loss of the protective grounding of the instrument.
There was no U.S. distribution of the affected unit. Distribution was made to Panama and the United Kingdom.
The recalled product
- 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…
- Manufacturer
- Inova Diagnostics Incorporated
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial number 4316
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Inova Diagnostics Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Inova Diagnostics Incorporated
See all →- HighInova Diagnostics Recalls QUANTA-Lyser 240 IFA Due to Power Supply Defect
FDA (Devices) · 2018-04-04
Same hazard · electrical shock
See all →- High
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