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
Reported: December 18, 2019 Initiated: October 28, 2019 #Z-0669-2020
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).
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 712 units
- Distribution
- US Nationwide distribution.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 712 units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0669-2020.
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