FDA-Device2013-05-15Class II
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
Siemens Healthcare Diagnostics, Inc.
Hazard
Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
Sold states
US Nationwide Distribution including Puerto Rico.
Affected count
21,608 boxes = 432,160 panels
Manufactured in
2040 Enterprise Blvd, N/A, West Sacramento, CA, United States
Products
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1272-2013Don't want to check this manually?
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