Recall Z-1254-2019— Randox Laboratories Ltd.
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2019-04-03, terminated 2019-10-09. FDA's recall record names no specific 510(k) clearance for this event. 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: The target values and ranges in these lots are incorrect..
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-03
- Terminated
- 2019-10-09
- Firm location
- Crumlin (North), N/A, Ireland
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.