Sight Diagnostics recalls

Sight Diagnostics has 4 recalls on record with the FDA and USDA, the earliest in 2021 and the latest reported on 3 Jul 2024. 3 are still ongoing. The most frequent reason is device malfunction.

Total recalls4since 2021

Last 12 months0reported

Class I00% of total

Ongoing3latest 3 Jul 2024

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 4 100%Class III 0 0%

Why sight diagnostics is recalled

Product types

Test Kits & Diagnostics375%
Medical Software125%

By year

2024125%
2022250%
2021125%

Ongoing sight diagnostics recalls

3 active

Reported	Class	Recall	Company	Reason	Where
3 Jul 2024Device	CLASS II	Sight OLO CBC Test Kit recalled by Sight Diagnostics	Sight Diagnostics	Other	Nationwide
3 Aug 2022Device	CLASS II	Sight OLO, Automated Hematology Analyzer recalled by Sight Diagnostics	Sight Diagnostics	Device Malfunction	Nationwide
27 Apr 2022Device	CLASS II	The Sight OLO device is a computer vision based platform recalled	Sight Diagnostics	Lead & Heavy Metals	Nationwide

All sight diagnostics recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
3 Jul 2024Device	CLASS II	Sight OLO CBC Test Kit recalled by Sight Diagnostics	Sight Diagnostics	Other	Nationwide
3 Aug 2022Device	CLASS II	Sight OLO, Automated Hematology Analyzer recalled by Sight Diagnostics	Sight Diagnostics	Device Malfunction	Nationwide
27 Apr 2022Device	CLASS II	The Sight OLO device is a computer vision based platform recalled	Sight Diagnostics	Lead & Heavy Metals	Nationwide
29 Sep 2021Device	CLASS II	Sight OLO-E1/U1 recalled by Sight Diagnostics	Sight 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.