Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0669-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190

Product Classification:

Class II

Date Initiated: October 28, 2019

Date Posted: December 18, 2019

Recall Number: Z-0669-2020

Event ID: 84260

Reason for Recall:

Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).

Status: Terminated

Product Quantity: 712 units

Code Information:

Anti-HAV IgM APP-file (version 06.05-101)

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated