Reported Dec 4, 2019 · Terminated
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended…
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 11800 SW 147th Ave · Miami, FL · 33196-2500
Is this the product you have?
- UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker
- Stainer II (DxH SMS II) - Product UsageThe
- intended use is as followsThe 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
- Lot codes and dates
- Catalog Number 775222
- Serial numbers
902 of 902 codes
AS39017AS40018AT35013AT35014AT35015AT35017AT35018AT40020AT40021AT40022AT40024AT40025AT40027AT40030AT45031AT45032AT45034AT45035AT49037AT49041AT49044AT49045AT49046AT49047AT49048AT49049AT49050AT49051AT49055AT49057AT49058AT49059AT49060AT49061AT49062AT49063AT49064AT49065AU01004AU01005AU01007AU01009AU01010AU01011AU01012AU01014AU01015AU01016AU01017AU01020AU01021AU01022AU01023AU01024AU01025AU01028AU01029AU01030AU08041AU08043
- Serial Numbers
AZ30002AZ30003AZ30004AZ39005BA14002. Catalog Number C11477
- Serial Numbers
149 of 149 codes
BB11109BB11110BB12111BB12117BB12118BB12119BB12120BB12121BB12122BB12123BB18124BB18125BB18126BB18127BB18128BB18129BB18130BB18133BB23134BB23135BB23136BB31145BB31146BB31147BB31148BB31149BB31150BB36157BB36158BB36159BB36160BB36161BB36162BB43163BB43164BB43165BB43166BB43167BB43168BB47169BB47170BB47171BB47172BB47173BB47174BB47176BB47177BC01101BC01102BC01103BC01104BC01105BC04106BC04108BC04109BC04110BC04111BC04112BC04113BC04114
- Amount recalled
- 1,056 (418 US, and 638 OUS)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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