FDA-Device2019-12-04Class II
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
Beckman Coulter, Inc.
Hazard
When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.
Sold states
Worldwide distribution - US Nationwide distribution and countries of Australia, Bahrain, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Affected count
1,056 (418 US, and 638 OUS)
Manufactured in
11800 SW 147th Ave, Miami, FL, United States
Products
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2020Don'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