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Stanbio Laboratory, LP FDA Recalls

7 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.Class IIOct 2, 2023Deterioration in the stability of the Test Strips results in	Deterioration in the stability of the Test Strips results in diminished low-range detection capability and ina	Class IIDevices	Oct 2, 2023
Separation Technology Creamatocrit Plus, Catalog Number: 100-146Class IIMar 16, 2022The device was being marketed as an IVD without a 510(k). Th	The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these brea	Class IIDevices	Mar 16, 2022
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.Class IIIJul 12, 2021Deterioration in the stability of the reagents which has res	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quali	Class IIIDevices	Jul 12, 2021
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.Class IIIJul 12, 2021Deterioration in the stability of the reagents which has res	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quali	Class IIIDevices	Jul 12, 2021
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.Class IIIJul 12, 2021Deterioration in the stability of the reagents which has res	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quali	Class IIIDevices	Jul 12, 2021
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.Class IIIJul 12, 2021Deterioration in the stability of the reagents which has res	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quali	Class IIIDevices	Jul 12, 2021
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.Class IIIJul 12, 2021Deterioration in the stability of the reagents which has res	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quali	Class IIIDevices	Jul 12, 2021

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