Randox Lipase Assay: Lipase Colorimetric Reagent recall
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro…
Why was Randox Lipase Assay: Lipase Colorimetric Reagent recalled?
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent 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: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135
- Product
- Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro…
- Recalling firm
- RANDOX LABORATORIES, LTD.
- Quantity
- 2219 kits
- 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)