FDA-Device2015-05-06Class II
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.
Beckman Coulter, Inc.
Hazard
Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged without desiccants. The substrates on a panel packaged without a desiccant may deteriorate over time due to exposure to additional moisture in the panel pouch.
Sold states
Nationwide Distribution including Puerto Rico and to the states of : CT, GA, NC, OK, NY, SC, KY, TN, CA, WA, OR, NJ, OH, PA, FL, MI, TX, WI, MO and NH.
Affected count
664 panel boxes
Manufactured in
2040 Enterprise Blvd, West Sacramento, CA, United States
Products
MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1524-2015Don'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