Z-1057-2019 Class II Terminated
FDA device recall Z-1057-2019 was initiated by Randox Laboratories Ltd. on February 13, 2019 and is designated Class II. Reason for recall: An error in the assignment of the control range pH in Blood Gas Control The recall status is terminated (terminated April 14, 2020). Affected quantity: 1 kit.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 13, 2019
- Termination Date
- April 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 kit
Product Description
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.
Reason for Recall
An error in the assignment of the control range pH in Blood Gas Control
Distribution Pattern
US Distribution to state of: WV
Code Information
Lot Code: 184BG GTIN: 05055273227116