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Terminated

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

FDA Recall Z-1001-2020 · Posted None

Recalling FirmClinical Diagnostic Solutions, Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2020-01-02
Date Terminated2022-11-03
Product Quantity261

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083420MEDONIC M SERIESBoule Medical AB · 2009-02-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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