FDAFDA · Food and drugs·Recall number Z-1001-2020
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Published February 12, 2020 · Recall initiated: January 2, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Clinical Diagnostic Solutions, Inc.
- Distributor
- Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.
- Lot
- Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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