Recall Z-0669-2020— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0669-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-28

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2019-10-28, terminated 2022-06-28. It names one FDA 510(k) clearance: K093955. Product: 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. Reason: 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)..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-28
Terminated: 2022-06-28
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K093955 — ANTI-HAV IGMRoche Diagnostics·cleared 2010-06-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.