FDA-Device2019-05-08Class II
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
Randox Laboratories Ltd.
Hazard
The target values and ranges in these lots are incorrect.
Sold states
The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
Affected count
14 kits
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1254-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief