Z-1001-2020Class II

Medonic M-Series Hematology Analyzer M16S BD ABR US

Name: Z-1001-2020 Medonic M-Series Hematology Analyzer M16S BD ABR US
Creator: Clinical Diagnostic Solutions, Inc.
Published: 2020-01-02
License: https://open.fda.gov/license/

Clinical Diagnostic Solutions, Inc. / initiated 2020-01-02 / Terminated / root cause: software

FDA source

Clinical Diagnostic Solutions, Inc. began a recall of Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011 on 2020-01-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1001-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-02
Posted: 2020-02-05
Terminated: 2022-11-03
Recalling firm: Clinical Diagnostic Solutions, Inc.
Product: Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: software
FDA root cause: Software design
Action: Consignees notified via email and postal delivery with recall letter dated 01/02/2020. The letter identified affected product, stated reason for recall, and provided specific actions to follow. A Recall Acknowledgement Form was requested to be returned by email, postal delivery, or fax. Clinical Diagnostic Solutions Inc. is handling US consignees only. Boule Medical AB is handling OUS consignees.
Quantity in commerce: 261
Distribution: Worldwide distribution. US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine. No governmental, Canadian, or Mexican consignees.
Product codes and lots: Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1001-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1001-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-05

Product code GKZ

K083420Class IIMedonic M SeriesBoule Medical AB / cleared 2009-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)