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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:148663

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

Official recall number

Z-2692-2016

Evidence summary

Product code
BSZ
Recall status
Terminated
Event initiated
August 04, 2016
Root cause
Under Investigation by firm
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-2692-2016

Field note

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