Z-1979-2019Class II

The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the...

Name: Z-1979-2019 The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the...
Creator: Roche Diagnostics Corporation
Published: 2019-06-03
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-06-03 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corporation began a recall of 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... on 2019-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1979-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-03
Posted: 2019-07-16
Terminated: 2020-08-28
Recalling firm: Roche Diagnostics GmbH
Product: 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.
Product code: CZP Iga, Antigen, Antiserum, Control
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Urgent Medical Device Correction notification letters dated 6/3/19 were sent to customers.
Quantity in commerce: 8 units
Distribution: The products were distributed to the following US states: AL, IN, and KY.
Product codes and lots: Lot 368756

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1979-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1979-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-24	2019-07-16

Product code CZP

K040435Class IIRoche Diagnostics Tina-Quant Iga Gen.2Roche Diagnostics Corp. / cleared 2004-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)