RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Reported: December 8, 2021 Initiated: November 1, 2021 #Z-0328-2022
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
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 15 kits
- Distribution
- US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
- Location
- Crumlin (North)
Frequently Asked Questions
What product was recalled? ▼
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200. Recalled by Randox Laboratories Ltd.. Units affected: 15 kits.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 8, 2021. Severity: Moderate. Recall number: Z-0328-2022.
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