PlainRecalls
FDA Devices Moderate Class II Terminated

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC 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

Reported: September 7, 2016 Initiated: August 4, 2016 #Z-2692-2016

Product Description

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC 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

Reason for Recall

Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
759 units total (358 units in US)
Distribution
Worldwide Distribution to US (nationwide) and Internationally to Australia, Belgium, Canada, China, Croatia, Czech Republic, France, Germany, Hong Kong, India, Israel, Italy, Japan, Kuwait, Malaysia, Mayotte, Mexico, New Zealand, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, and Vietnam.
Location
Brea, CA

Frequently Asked Questions

What product was recalled? ▼
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC 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. Recalled by Beckman Coulter Inc.. Units affected: 759 units total (358 units in US).
Why was this product recalled? ▼
Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2016. Severity: Moderate. Recall number: Z-2692-2016.

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