FDAClass IIMay 8, 2019

G-6-PDH Deficient Control recall

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…

Why was G-6-PDH Deficient Control recalled?

The target values and ranges in these lots are incorrect.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 687PD 700PD 715PD

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…
Recalling firm
Randox Laboratories Ltd.
Quantity
14 kits
Distribution
The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
Recall date
May 8, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls