Ortho-Clinical Diagnostics recalls

Ortho-Clinical Diagnostics has 311 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 24 Sep 2025. 79 are still ongoing.

Total recalls311since 2012

Last 12 months0reported

Class I00% of total

Ongoing79latest 24 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 1 3 0Feb 0 0 0May 2 8 1Aug 2 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 284 91%Class III 27 9%

Why ortho-clinical diagnostics is recalled

Product types

By year

2025165%
2024248%
2023217%
202293%
2021134%
2020258%
20193511%
2018258%
201793%
2016299%

Ongoing ortho-clinical diagnostics recalls

79 active

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vitros Chemistry Products LAC Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS II	Vitros Chemistry Products Ca Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides (Japan) recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products Performance Verifier II recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide

All ortho-clinical diagnostics recalls, newest first

311 total

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vitros Chemistry Products LAC Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS II	Vitros Chemistry Products Ca Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides (Japan) recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products Performance Verifier II recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products Performance Verifier recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
9 Jul 2025Device	CLASS II	Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
9 Jul 2025Device	CLASS II	Vitros 4600 Chemistry System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
9 Jul 2025Device	CLASS II	Vitros XT 7600 Integrated System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
9 Jul 2025Device	CLASS II	Vitros Chemistry Products OP Reagent Gen recalled	Ortho-Clinical Diagnostics	Packaging Defects	Nationwide
18 Jun 2025Device	CLASS II	Solana¿ Bordetella Complete Assay Solana Bordetella kit recalled	Ortho-Clinical Diagnostics	Potency & Assay	NY
4 Jun 2025Device	CLASS II	Vitros Chemistry Products CRP Slides recalled	Ortho-Clinical Diagnostics	Other	Nationwide
29 Jan 2025Device	CLASS II	Vitros 3600 Immunodiagnostic System recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Vitros XT 7600 Integrated System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
4 Dec 2024Device	CLASS II	Vitros Chemistry Products CRP Slides- In vitro diagnostic recalled	Ortho-Clinical Diagnostics	Other	Nationwide
28 Aug 2024Device	CLASS II	The Vitros XT Chemistry Products Alb-tp Slides is a single recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
21 Aug 2024Device	CLASS II	Vitros Immunodiagnostic Vitros Folate Reagent Pack 1/2 recalled	Ortho-Clinical Diagnostics	Other	Nationwide
10 Jul 2024Device	CLASS II	Vitros Chemistry Products FS Diluent Pack 3 comes recalled	Ortho-Clinical Diagnostics	Other	Nationwide
10 Jul 2024Device	CLASS III	Vitros Chemistry Products Calibrator Kit-Vitor used recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
19 Jun 2024Device	CLASS II	Vitros Immunodiagnostic Products Anti HBs Calibrators recalled	Ortho-Clinical Diagnostics	Other	Nationwide
12 Jun 2024Device	CLASS III	Vitros Immunodiagnostic Products Vitamin B12 Range Verifier recalled	Ortho-Clinical Diagnostics	Potency & Assay	Nationwide
3 Apr 2024Device	CLASS II	Vitros Performance Verifier II recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Other	Nationwide
3 Apr 2024Device	CLASS II	Vitros Performance Verifier I recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Other	Nationwide
13 Mar 2024Device	CLASS II	Vitros XT 3400 Chemistry System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
13 Mar 2024Device	CLASS II	Vitros 3600 Immunodiagnostic System recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
13 Mar 2024Device	CLASS II	Vitros 4600 Chemistry System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
13 Mar 2024Device	CLASS II	Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
13 Mar 2024Device	CLASS II	Vitros 4600 Chemistry System recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	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.