This is an in vitro diagnostic product intended for use recall
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42…
Why was This is an in vitro diagnostic product intended for use recalled?
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
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: 961UE onwards GTN: 05055273200966
- Product
- This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 307 kits
- Distribution
- Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
- Recall date
- September 18, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)