Z-1254-2019 Class II Terminated
FDA device recall Z-1254-2019 was initiated by Randox Laboratories Ltd. on April 3, 2019 and is designated Class II. Reason for recall: The target values and ranges in these lots are incorrect. The recall status is terminated (terminated October 9, 2019). Affected quantity: 14 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- April 3, 2019
- Termination Date
- October 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 kits
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.
Distribution Pattern
The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
Code Information
Lot Numbers: 687PD 700PD 715PD