Home / Recalls / Clinical Diagnostic Solutions, Inc. / Z-1001-2020

Z-1001-2020 Class II Terminated

Recalled by Clinical Diagnostic Solutions, Inc. — Plantation, FL

Recall Details

Product Type
Devices
Report Date
February 12, 2020
Initiation Date
January 2, 2020
Termination Date
November 3, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
261

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.

Distribution Pattern

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

Code Information

Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019

Other recalls by Clinical Diagnostic Solutions, Inc.

  • Z-1436-2014 Class II — Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for i (February 24, 2013)
  • Z-0189-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0190-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0191-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0193-2013 Class III — Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control (August 4, 2010)
  • Z-0194-2013 Class III — Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a c (August 4, 2010)