Medonic M-Series Hematology Analyzer M16S BD ABR US recall
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Why was Medonic M-Series Hematology Analyzer M16S BD ABR US 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019
- Product
- Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
- Recalling firm
- Clinical Diagnostic Solutions, Inc.
- Quantity
- 261
- Distribution
- Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.
- Recall date
- February 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)