Randox Laboratories Ltd. recalls Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal…
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- Randox Laboratories
- Product
- Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
- Classification
- Class II
- Units
- Nationwide Distribution - MD, OR, PR, MT, WV
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to…
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FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of WV, NC.Official notice → - 2022-07-27
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FDA · DeviceRandox Laboratories Ltd.Domestic distribution to WV and PR. International distribution to Bangladesh,…Official notice → - 2021-12-08
- US
Randox Laboratories Ltd. recalls RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
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
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.Official notice →
Other drugs & medical recalls in the United States
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