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Recall Observatory FDA recall evidence

Device product

Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

Z-2150-2019

June 11, 2019

Class II

Product summary

Firm
Randox Laboratories, Limited
Event
Event 83155
Status
Terminated
Classification
Class II
Quantity
149 (US)
Official record key
device-enforcement:Z-2150-2019

Official wording

Reason: The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

Code information: 1306UN, 1308UN, 1309UN

Distribution pattern: US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.