Device product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Z-0328-2022
Product summary
- Event
- Event 88999
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 kits
- Official record key
device-enforcement:Z-0328-2022
Official wording
Reason: 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
Code information: Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
Distribution pattern: US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
Derived failure modes
-
Unknown
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