Z-0623-2019Class II

Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography...

Name: Z-0623-2019 Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography...
Creator: Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Published: 2018-11-01
License: https://open.fda.gov/license/

Trinity Biotech USA / initiated 2018-11-01 / Terminated

FDA source

Clark Laboratories, Inc. (dba,Trinity Biotech USA) began a recall of Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange... on 2018-11-01. FDA classified it as Class II and gives the reason as "lack of 510K". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0623-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-01
Posted: 2018-12-18
Terminated: 2022-06-21
Recalling firm: Trinity Biotech USA
Product: Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Product code: GKA Abnormal Hemoglobin Quantitation
Reason for recall: lack of 510K
FDA root cause: No Marketing Application
Action: The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items.
Quantity in commerce: 216 units
Distribution: IL, WV, NJ, AZ, MD, UT
Product codes and lots: all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0623-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0620-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0621-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0622-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0623-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0624-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18

Product code GKA

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)