Recall Z-2692-2016 ยท BSZ Gas-Machine, Anesthesia
Beckman Coulter Inc.
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, a
| Date | Aug 4, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an Urgent Medical Device recall letter dated August 4, 2016, to all affected customers to inform them that 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. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the recall notice were instructed to contact Beckman Coulter Customer Support Center: http://www.beckmancoulter.com/customersupport/ |
| Quantity | 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 Ko |
| FDA record | Open on fda.gov |