Stanbio Laboratory, LP recalls

9 recalls on record · latest: October 2, 2023

Official U.S. recall history for Stanbio Laboratory, LP, compiled from official government records.

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Stanbio Laboratory, LP recalls STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

October 2, 2023 · Medical device recalls Moderate risk Deterioration in the stability of the Test Strips results in diminished low-ran…

Stanbio Laboratory, LP recalls Separation Technology Creamatocrit Plus, Catalog Number: 100-146

March 16, 2022 · Medical device recalls Moderate risk The device was being marketed as an IVD without a 510(k). Therefore, performanc…

Stanbio Laboratory, LP recalls Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

July 12, 2021 · Medical device recalls Deterioration in the stability of the reagents which has resulted in lower than…

Stanbio Laboratory, LP recalls Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.

July 12, 2021 · Medical device recalls Deterioration in the stability of the reagents which has resulted in lower than…

Stanbio Laboratory, LP recalls Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

July 12, 2021 · Medical device recalls Deterioration in the stability of the reagents which has resulted in lower than…

Stanbio Laboratory, LP recalls Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.

July 12, 2021 · Medical device recalls Deterioration in the stability of the reagents which has resulted in lower than…

Stanbio Laboratory, LP recalls Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.

July 12, 2021 · Medical device recalls Deterioration in the stability of the reagents which has resulted in lower than…

Stanbio Laboratory, LP recalls RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-3…

February 13, 2018 · Medical device recalls Moderate risk All patient serum samples yield a weakly positive test result.

Stanbio Laboratory, LP recalls Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H…

February 8, 2018 · Medical device recalls Moderate risk The US prong (type A) adapter plate may crack, break, or detach and remain in t…