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Recall Observatory FDA recall evidence

Device product

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

Z-1547-2020

February 18, 2020

Class II

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 85030
Status
Ongoing
Classification
Class II
Quantity
186 total, 27 USA
Official record key
device-enforcement:Z-1547-2020

Official wording

Reason: The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

Code information: Lot 306UL

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.