Recall Z-1001-2020— Clinical Diagnostic Solutions, Inc.

Name: FDA recall Z-1001-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-02

Class II · Terminated

Class II FDA medical device recall by Clinical Diagnostic Solutions, Inc., initiated 2020-01-02, terminated 2022-11-03. It names one FDA 510(k) clearance: K083420. Product: Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011. Reason: 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..

Recalling firm: Clinical Diagnostic Solutions, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-01-02
Terminated: 2022-11-03
Firm location: Plantation, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K083420 — MEDONIC M SERIESBoule Medical AB·cleared 2009-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.