Z-1255-2019 Class II Terminated
FDA device recall Z-1255-2019 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: 10 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
- 10 kits
Product Description
G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 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: 676PD 701PD 716PD