FDA-Device2023-01-11Class II
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
Randox Laboratories Ltd.
Hazard
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Sold states
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Affected count
146 units US
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0903-2023Don't want to check this manually?
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