Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
This recall has been terminated (originally issued February 13, 2019).
- Recall Initiated
- February 13, 2019
- Terminated
- April 14, 2020
- Recall Number
- Z-1057-2019
- Quantity
- 1 kit
- Official Source
- View on FDA website ↗
Reason for Recall
An error in the assignment of the control range pH in Blood Gas Control
Distribution
US Distribution to state of: WV
Lot / Code Info
Lot Code: 184BG GTIN: 05055273227116
Root Cause
Process control
Action Taken
The firm, Randox Laboratories Ltd, sent an "Urgent Medical Device Correction " letter dated 2/13/2019 to its customer on 2/13/2019 via email. The letter describes the product, problem and actions to be taken. The customer was instructed todo the following: " Please replace the amended value sheet within the kit of any remaining stock. " Discuss the contents of this notice with your Medical Director. " Randox Laboratories Ltd is not recommending a review of previous results as any issue would be observed at the time of use. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services by email at technical.services@randox.com, or telephone +44 (0)28 9442 2413 or Email: vigilance@randox.com.