RANDOX CHOL-cholesterol recall
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Why was RANDOX CHOL-cholesterol 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
- Product
- RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 15 kits
- Distribution
- US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
- Recall date
- December 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)