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Recall Observatory FDA recall evidence

Device product

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

Z-2207-2019

June 10, 2019

Class III

Product summary

Firm
Randox Laboratories, Limited
Event
Event 83153
Status
Terminated
Classification
Class III
Quantity
4 kits (US)
Official record key
device-enforcement:Z-2207-2019

Official wording

Reason: The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

Code information: 205SL

Distribution pattern: Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.