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Recall Observatory FDA recall evidence

Device product

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.

Z-2753-2020

June 26, 2020

Class II

Product summary

Firm
RANDOX LABORATORIES, LTD.
Event
Event 86039
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2753-2020

Official wording

Reason: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.

Code information: Catalogue Numbers: LI015/000/UL, LI015/003/UL, LI015/000/UL Lot #: 1049LI, 1051LI

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.