livehealth.store

TEM Systems recalls

TEM Systems has 3 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 2 Nov 2016.

Total recalls3since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Nov 2016

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 3 100%Class III 0 0%

Why tem systems is recalled

Other Reasons267%
Potency & Assay133%

Product types

Patient Monitors267%
Other Medical Devices133%

By year

2016267%
2015133%

All tem systems recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
2 Nov 2016Device	CLASS II	ex-TEM Assay for Rotem delta Thromboelastometry System recalled	TEM Systems	Potency & Assay	Nationwide
16 Mar 2016Device	CLASS II	Rotrol P Control for Rotem delta Thromboelastometry System recalled	TEM Systems	Other	27 states
15 Apr 2015Device	CLASS II	Rotrol P Control for Rotem delta Thromboelastometry System recalled	TEM Systems	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.