FDA-Device2019-08-14Class III
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Randox Laboratories, Limited
Hazard
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.
Sold states
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.
Affected count
4 kits (US)
Manufactured in
Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, United Kingdom
Products
Assayed Bovine Multi-Sera Level 1, Model No. AL1027
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2019Don't want to check this manually?
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