Recall Z-2751-2020— RANDOX LABORATORIES, LTD.
Class II · Terminated
Class II FDA medical device recall by RANDOX LABORATORIES, LTD., initiated 2020-06-26, terminated 2020-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches..
- Recalling firm
- RANDOX LABORATORIES, LTD.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-26
- Terminated
- 2020-10-19
- Firm location
- Crumlin Colorado Antrim, United Kingdom
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.
Reason for recall
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Data sourced from openFDA. This site is unofficial and independent of the FDA.