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
This recall has been terminated (originally issued April 3, 2019).
- Recall Initiated
- April 3, 2019
- Terminated
- October 9, 2019
- Recall Number
- Z-1255-2019
- Quantity
- 10 kits
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot Numbers: 676PD 701PD 716PD
Root Cause
Nonconforming Material/Component
Action Taken
Randox sent an Urgent Medical Device Correction notification letters dated 4/2/19 to affected customers. The letter identified the affected product, problem and action to be taken: " Discontinue use of and quarantine any of the above devices immediately. " Discuss the contents of this notice with your Medical Director. " Review results generated with the affected batches in line with the clinical profile of the patient. " Inform all relevant staff members. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall immediately by providing a copy of this FSN and response form. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. For questions contact Randox Technical Services.