Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies Recalled by Roche Diagnostics Corporation Due to Calibration failures with Std.E, Sens.E, or Dup.E error...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Corporation directly.
Affected 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.
Quantity: 8 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 3 states: AL, IN, KY
About Roche Diagnostics Corporation
Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report