LIPASE (LPS) recallZ-2751-2020 · Randox Laboratories, Ltd. · initiated Jun 26, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
Randox sent an urgent medical device correction notification dated June 22, 2020 explaining the current failure with select lots of Lipase Colorimetric products. The firm advised customers to scrap all effected product, keep proof of destruction, review replacements needs, review results of patients generated using affected batches and return the firm's response card.
Recall details
- Recall number
- Z-2751-2020
- Status
- Terminated
- Initiated by the company
- Jun 26, 2020
- Posted by the FDA
- Aug 4, 2020
- Recalling firm
- Randox Laboratories, Ltd.
- Quantity
- 2219 kits
- Product code
- CHI
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Product description
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Code information (models, lots, serial numbers)
Catalogue Numbers: LI3837, LI7979, LI8050, LI8361 GTIN: 05055273204230, 05055273204247, 05055273209136, 05055273214284 Lot #: 507360, 497086, 497053, 497038, 502135
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- LIPASE (LPS) LI3837Randox Laboratories Limited · Lipase-Esterase, Enzymatic, Photometric, Lipase1 recall0 reports
- LIPASE (LPS) LI7979Randox Laboratories Limited · Lipase-Esterase, Enzymatic, Photometric, Lipase1 recall0 reports
- LIPASE (LPS) LI8050Randox Laboratories Limited · Lipase-Esterase, Enzymatic, Photometric, Lipase1 recall0 reports
- LIPASE (LPS) LI8361Randox Laboratories Limited · Lipase-Esterase, Enzymatic, Photometric, Lipase1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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