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Recall Observatory FDA recall evidence

Device product

Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

Z-1001-2020

January 02, 2020

Class II

Product summary

Firm
Clinical Diagnostic Solutions, Inc.
Event
Event 84614
Status
Terminated
Classification
Class II
Quantity
261
Official record key
device-enforcement:Z-1001-2020

Official wording

Reason: A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.

Code information: Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019

Distribution pattern: Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.