Randox Lipase recall
Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and…
Why was Randox Lipase recalled?
According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running order for all instruments using these reagents to ensure Lipase is not place directly before or after LDL or Triglycerides. A correction was made to the IFU for the Lipase assay and all customers who purchased the Lipase kit in the USA were contacted with the updated instruction.
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?
Catalogue number: LI3837, LI7979, LI8050, LI8361
- Product
- Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 18
- Distribution
- US Nationwide Distribution
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)