FDA-Device2019-07-24Class II
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
Roche Diagnostics Corporation
Hazard
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
Sold states
The products were distributed to the following US states: AL, IN, and KY.
Affected count
8 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1979-2019Don't want to check this manually?
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