Stanbio Laboratory recalls

Stanbio Laboratory has 9 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 13 Dec 2023. 1 is still ongoing. The most frequent reason is potency & assay.

Total recalls9since 2018

Last 12 months0reported

Class I00% of total

Ongoing1latest 13 Dec 2023

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 44%Class III 5 56%

Why stanbio laboratory is recalled

Product types

By year

2023111%
2022111%
2021556%
2018222%

Ongoing stanbio laboratory recalls

1 active

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023Device	CLASS II	Stat-Site M Bhb Test Strips, used recalled by Stanbio Laboratory	Stanbio Laboratory	Lead & Heavy Metals	Nationwide

All stanbio laboratory recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023Device	CLASS II	Stat-Site M Bhb Test Strips, used recalled by Stanbio Laboratory	Stanbio Laboratory	Lead & Heavy Metals	Nationwide
20 Apr 2022Device	CLASS II	Separation Technology Creamatocrit Plus recalled by Stanbio Laboratory	Stanbio Laboratory	Lead & Heavy Metals	Nationwide
11 Aug 2021Device	CLASS III	Cardinal Health Beta-Hydroxybutyrate LiquiColor recalled	Stanbio Laboratory	Potency & Assay	Nationwide
11 Aug 2021Device	CLASS III	Beta-Hydroxybutyrate LiquiColor recalled by Stanbio Laboratory	Stanbio Laboratory	Potency & Assay	Nationwide
11 Aug 2021Device	CLASS III	Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent recalled	Stanbio Laboratory	Potency & Assay	Nationwide
11 Aug 2021Device	CLASS III	Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent recalled	Stanbio Laboratory	Potency & Assay	Nationwide
11 Aug 2021Device	CLASS III	Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled) recalled	Stanbio Laboratory	Potency & Assay	Nationwide
5 Sep 2018Device	CLASS II	Stanbio AC power adapter for the HemoPoint H2 meter recalled	Stanbio Laboratory	Device Malfunction	Nationwide
21 Mar 2018Device	CLASS II	RaPET¿ RF Latex Reagent used as a component recalled	Stanbio Laboratory	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.