Z-1222-2018Class II

QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system...

Name: Z-1222-2018 QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system...
Creator: Inova Diagnostics Incorporated
Published: 2018-01-26
License: https://open.fda.gov/license/

Inova Diagnostics, Inc. / initiated 2018-01-26 / Terminated / root cause: manufacturing process

FDA source

Inova Diagnostics Incorporated began a recall of 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... on 2018-01-26. FDA classified it as Class II and gives the reason as "The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1222-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-26
Posted: 2018-03-27
Terminated: 2018-05-22
Recalling firm: Inova Diagnostics, Inc.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Serial number 4316

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1222-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1221-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27
Z-1222-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-27

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)