The Recall Desk

Manufacturer

Stanbio Laboratory, LP

9 recalls in our database name Stanbio Laboratory, LP as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
1
Most recent
2023-12-13

Of the 9 recalls from Stanbio Laboratory, LP we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (11%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • HighFDA (Devices)·Z-0490-2024·2023-12-13

    Blood Ketone Test Strips Recalled for False Negative Results

    Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.

    Product
    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2022·2022-04-20

    Breast Milk Analyzer Lacks FDA Validation, Risks Sub-optimal Infant Nutrition

    Stanbio Laboratory's Creamatocrit Plus breast milk analyzer was marketed without required FDA 510(k) clearance. Its performance has not been validated, and erroneous results could lead to inadequate nutritional supplementation for infants.

    Product
    Separation Technology Creamatocrit Plus, Catalog Number: 100-146
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2021·2021-08-11

    In Vitro Diagnostic Reagent Recalled for Reagent Stability Deterioration

    Stanbio Laboratory is recalling Synchron Beta-Hydroxybutyrate diagnostic reagent due to reagent deterioration causing quality control values to fall out of expected range.

    Product
    Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2203-2021·2021-08-11

    In Vitro Diagnostic Reagent Recalled Due to Stability Deterioration

    Cardinal Health Beta-Hydroxybutyrate diagnostic reagent has been recalled due to stability deterioration causing out-of-range quality control values. No illnesses have been reported.

    Product
    Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2021·2021-08-11

    Diagnostic Reagent Stability Issues Lead to Out-of-Range Quality Control Values

    Stanbio Laboratory is recalling Beta-Hydroxybutyrate LiquiColor diagnostic reagent due to reagent deterioration that causes lower than expected or out-of-range quality control values, affecting test accuracy.

    Product
    Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2200-2021·2021-08-11

    Beta-Hydroxybutyrate Diagnostic Reagent Recalled for Stability Degradation

    Stanbio Laboratory recalled Beta-Hydroxybutyrate Reagent A due to deterioration in reagent stability. The degradation resulted in out-of-range Quality Control values that could affect diagnostic accuracy.

    Product
    Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2202-2021·2021-08-11

    Beta-Hydroxybutyrate diagnostic reagent recalled due to stability degradation

    Stanbio Laboratory is recalling Cardinal Health Beta-Hydroxybutyrate in vitro diagnostic reagents due to reagent instability causing out-of-range quality control values that may affect diagnostic accuracy.

    Product
    Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2926-2018·2018-09-05

    Stanbio AC Power Adapter Recall for HemoPoint H2 Meter

    Stanbio Laboratory is recalling AC power adapters for the HemoPoint H2 meter because the adapter plate may crack or detach, exposing live electrical contacts.

    Product
    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1070-2018·2018-03-21

    Stanbio Recalls RaPET RF Latex Reagent Due to False Positive Test Results

    Stanbio Laboratory is recalling RaPET RF Latex Reagent because it causes all patient serum samples to yield weakly positive test results.

    Product
    RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) P
    Category
    Medical Device
    Distribution
    Distributed nationwide