Clinical Diagnostic Solutions recalls

Clinical Diagnostic Solutions has 7 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 12 Feb 2020.

Total recalls7since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 12 Feb 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 29%Class III 5 71%

Why clinical diagnostic solutions is recalled

Product types

Patient Monitors686%
Test Kits & Diagnostics114%

By year

2020114%
2014114%
2012571%

All clinical diagnostic solutions recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
12 Feb 2020Device	CLASS II	Medonic M-Series Hematology Analyzer M16S BD ABR US Product recalled	Clinical Diagnostic Solutions	Packaging Defects	Nationwide
16 Apr 2014Device	CLASS II	Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology recalled	Clinical Diagnostic Solutions	Potency & Assay	Nationwide
14 Nov 2012Device	CLASS III	Boule Con-Diff Hematology Control recalled	Clinical Diagnostic Solutions	Other	32 states
14 Nov 2012Device	CLASS III	Boule Con-Diff Hematology Control recalled	Clinical Diagnostic Solutions	Other	32 states
14 Nov 2012Device	CLASS III	Boule Con-Diff Hematology Control recalled	Clinical Diagnostic Solutions	Other	32 states
14 Nov 2012Device	CLASS III	Boule Con-Diff Hematology Control 9 vials recalled	Clinical Diagnostic Solutions	Other	Nationwide
14 Nov 2012Device	CLASS III	Boule Con Diff US Tri Pack, 6 Vials recalled	Clinical Diagnostic Solutions	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.