Clinical Diagnostic Solutions, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1001-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 2, 2020

Date Posted: February 12, 2020

Recall Number: Z-1001-2020

Event ID: 84614

Reason for Recall:

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.

Status: Terminated

Product Quantity: 261

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.

Voluntary or Mandated:

Voluntary: Firm initiated