FDAFDA · Food and drugs·Recall number Z-1086-2022
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Published May 25, 2022 · Recall initiated: October 21, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide distribution - U.S. Nationwide distribution in the states of Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, and Washington. The countries of Belgium, Brazil, Colombia, Germany, Hong Kong, Indonesia, Italy, Japan, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, United Arab Emirates, Vietnam and Yemen.
- Lot
- Catalog Number: B1018-496 UDI-DI Code: 15099590690892 Serial Numbers: 49610039 49610040 49610041 49610042 49610043 49610044 49610045 49610046 49610047 49610048 49610050 49610051 49610052 49610053 49610054 49610055 49610056 49610057 49610058 49610059 49610060 49610062 49610063 49610064 49610065 49610066 49610067 49610068 49610069 49610070 49610071 49610072 49610073 49610074 49610075 49610078 49610079 49610080 49610081 49610082 49610083 49610084 49610085 49610086 49610087 49610088 49610089 49610090 49610091
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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