FDAClass IIAugust 12, 2020

Randox Lipase Assay: Lipase Colorimetric R1 Buffer recall

Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro…

Why was Randox Lipase Assay: Lipase Colorimetric R1 Buffer recalled?

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.

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 Numbers: LI011/004/UL, LI011/000/UL Lot #: 1048LI, 1050LI

Product
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro…
Recalling firm
RANDOX LABORATORIES, LTD.
Distribution
Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Recall date
August 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls