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Stanbio Laboratory Recalls
9 recalls on record · March 21, 2018 to December 13, 2023 · Medical Devices
Recalls by year
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23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 13, 2023Medical DevicesFDA
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.
Hazard: Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis.
April 20, 2022Medical DevicesFDA
Stanbio Laboratory, LP recalls Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Hazard: The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
August 11, 2021Medical DevicesFDA
Stanbio Laboratory, LP recalls Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
Hazard: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
August 11, 2021Medical DevicesFDA
Stanbio Laboratory, LP recalls Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Hazard: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
August 11, 2021Medical DevicesFDA
Stanbio Laboratory, LP recalls Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Hazard: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
August 11, 2021Medical DevicesFDA
Stanbio Laboratory, LP recalls Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Hazard: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
August 11, 2021Medical DevicesFDA
Stanbio Laboratory, LP recalls Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Hazard: Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
September 5, 2018Medical DevicesFDA
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
Hazard: The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.
March 21, 2018Medical DevicesFDA
Stanbio Laboratory, LP recalls RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30
Hazard: All patient serum samples yield a weakly positive test result.