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Terminated

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.

FDA Recall Z-1979-2019 · Posted None

Recalling FirmRoche Diagnostics Corporation
Recall StatusTerminated
Product CodeCZP
Date Initiated2019-06-03
Date Terminated2020-08-28
Product Quantity8 units

Reason for Recall

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.

Firm Action

Urgent Medical Device Correction notification letters dated 6/3/19 were sent to customers.

Root Cause

Material/Component Contamination

Distribution Pattern

The products were distributed to the following US states: AL, IN, and KY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp. · 2004-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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