Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Reported: August 12, 2020 Initiated: June 26, 2020 #Z-2753-2020
Product Description
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.
Reason for Recall
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
Details
- Recalling Firm
- RANDOX LABORATORIES, LTD.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
- Location
- Crumlin Colorado Antrim
Frequently Asked Questions
What product was recalled? ▼
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.. Recalled by RANDOX LABORATORIES, LTD..
Why was this product recalled? ▼
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 12, 2020. Severity: Moderate. Recall number: Z-2753-2020.
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