Reported Feb 12, 2020 · Terminated
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Clinical Diagnostic Solutions, 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: Clinical Diagnostic Solutions, Inc. · 1800 NW 65th Ave · Plantation, FL · 33313-4544
Is this the product you have?
- Medonic M-Series Hematology
- Analyzer M16S BD ABR US Product code
1400075OUS Product code 1400011
- Lot codes and dates
- Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019
- Amount recalled
- 261
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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