Z-1254-2019Class II

G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617

Name: Z-1254-2019 G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617
Creator: Randox Laboratories Ltd.
Published: 2019-04-03
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2019-04-03 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality... on 2019-04-03. FDA classified it as Class II and gives the reason as "The target values and ranges in these lots are incorrect". 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-1254-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-03
Posted: 2019-05-03
Terminated: 2019-10-09
Recalling firm: Randox Laboratories, Limited
Product: G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
Product code: JBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Reason for recall: The target values and ranges in these lots are incorrect.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Randox sent an Urgent Medical Device Correction notification letters dated 4/2/19 to affected customers. The letter identified the affected product, problem and action to be taken: " Discontinue use of and quarantine any of the above devices immediately. " Discuss the contents of this notice with your Medical Director. " Review results generated with the affected batches in line with the clinical profile of the patient. " Inform all relevant staff members. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall immediately by providing a copy of this FSN and response form. " Complete and return the response form 12187-QA to [email protected] within five working days. For questions contact Randox Technical Services.
Quantity in commerce: 14 kits
Distribution: The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
Product codes and lots: Lot Numbers: 687PD 700PD 715PD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1254-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1254-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02
Z-1255-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02

Product code JBL

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)