FDA recall Z-1979-2019

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.

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-06-03

Report date

2019-07-24

Termination date

2020-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1979-2019