Device product
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.
Z-1547-2020
Product summary
- Event
- Event 85030
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 186 total, 27 USA
- Official record key
device-enforcement:Z-1547-2020
Official wording
Reason: The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.
Code information: Lot 306UL
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.
Derived failure modes
-
Unknown
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.