Z-0328-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- November 1, 2021
- Termination Date
- March 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 kits
Product Description
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Reason for Recall
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
Distribution Pattern
US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
Code Information
Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130