Z-1547-2020 Class II Ongoing
FDA device recall Z-1547-2020 was initiated by Randox Laboratories Ltd. on February 18, 2020 and is designated Class II. Reason for recall: The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. The recall status is ongoing. Affected quantity: 186 total, 27 USA.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 18, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 186 total, 27 USA
Product Description
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
Reason for Recall
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.
Code Information
Lot 306UL