FDA-Device2013-06-19Class II
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Siemens Healthcare Diagnostics, Inc.
Hazard
The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
Sold states
Nationwide Distribution.
Affected count
683 units
Manufactured in
2040 Enterprise Blvd, N/A, West Sacramento, CA, United States
Products
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1525-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief