FDA recall Z-1254-2019

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

Reason for recall

The target values and ranges in these lots are incorrect.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-04-03

Report date

2019-05-08

Termination date

2019-10-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1254-2019