FDA-Device2021-04-14Class II
MicroScan WalkAway-96 plus Reconditioned Instrument
Beckman Coulter Inc.
Hazard
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
Sold states
U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen.
Affected count
9 systems
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
MicroScan WalkAway-96 plus Reconditioned Instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1373-2021Don't want to check this manually?
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