FDA recall Z-1001-2020

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-01-02

Report date

2020-02-12

Termination date

2022-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plantation, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2020