CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Quanta-Lyser 240 IFA, Part #GS0242 recalled
Inova Diagnostics Incorporated is recalling Quanta-Lyser 240 IFA, Part #GS0242. The recall was initiated on 26 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1221-2018
- FDA event ID
- 79380
- Recalling firm
- Inova Diagnostics Incorporated, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2018
- FDA classified
- 27 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Jan 2018 | Recall initiated by company | |
| 27 Mar 2018 | Classified by FDA | +60 days |
| 4 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
Where it was distributed
There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
Questions about this recall
Is Quanta-Lyser 240 IFA, Part #GS0242 recalled?
Yes. Inova Diagnostics Incorporated recalled Quanta-Lyser 240 IFA, Part #GS0242 on 26 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-1221-2018.
Why was it recalled?
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Which lots are affected?
Serial number 4314
Where was it sold?
There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Inova Diagnostics Incorporated
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Quanta-Lyser 240 EIA, Part #GS0241 recalled | Inova Diagnostics Incorporated | Other | CA |
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