CLASS II Device recall · Reported 8 May 2019 · FDA Enforcement Report

G-6-PDH Deficient Control (G-6-PDH Control D) recalled

Randox Laboratories is recalling G-6-PDH Deficient Control (G-6-PDH Control D), distributed in 7 states. The recall was initiated on 3 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 687PD 700PD 715PD

Quantity recalled14 kits

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-1254-2019
FDA event ID: 82550
Recalling firm: Randox Laboratories, Crumlin (North), N/A
Classification: Class II
Status: Terminated
Recall initiated: 3 Apr 2019
FDA classified: 2 May 2019
Reported: 8 May 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

3 Apr 2019	Recall initiated by company
2 May 2019	Classified by FDA	+29 days
8 May 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The target values and ranges in these lots are incorrect.

Product as listed by the FDA

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

Where it was distributed

The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.

Illinois North Carolina Ohio Pennsylvania Puerto Rico Wisconsin West Virginia

Stores named: Target

Questions about this recall

Is G-6-PDH Deficient Control (G-6-PDH Control D) recalled?

Yes. Randox Laboratories recalled G-6-PDH Deficient Control (G-6-PDH Control D) on 3 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1254-2019.

Why was it recalled?

The target values and ranges in these lots are incorrect.

Which lots are affected?

Lot Numbers: 687PD 700PD 715PD

Where was it sold?

The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.

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.

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