Fructosamine Calibrator recall
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical…
Why was Fructosamine Calibrator recalled?
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
498FR
- Product
- Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 85 kits
- Distribution
- US Distribution to states to: CA, ME. MI, and WV.
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)