The Recall Desk

Manufacturer

Biocare Medical, LLC

10 recalls in our database name Biocare Medical, LLC as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2024-11-13

Of the 10 recalls from Biocare Medical, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–10 of 10

  • ModerateFDA (Devices)·Z-0315-2025·2024-11-13

    Biocare Medical Recalls IHC Kits Due to Potential Staining Failure

    Biocare Medical is recalling specific IHC kits containing DAB Buffer because they may produce weak or no staining, leading to test failure.

    Product
    intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2021·2021-04-07

    Biocare Medical IntelliPath FLX Automated Staining Instrument Recall

    Biocare Medical is recalling 72 IntelliPath FLX instruments due to a software defect that may cause random movement and buffer dispensing errors.

    Product
    BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2291-2020·2020-06-17

    Biocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure

    Biocare Medical is recalling 4plus Streptavidin HRP Label kits because they may fail to stain, potentially causing invalid test results and delayed diagnoses.

    Product
    4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-3198-2018·2018-09-26

    Biocare Medical Recalls URO-3 Triple Stain Kits Due to Component Mislabeling

    Biocare Medical is recalling 11 URO-3 Triple Stain kits because two components were mislabeled, causing incorrect staining patterns in laboratory tests.

    Product
    URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2018·2018-07-11

    Biocare Medical Recalls Vulcan Fast Red Chromogen Kit Due to Stability Issue

    Biocare Medical is recalling Vulcan Fast Red Chromogen Kit 2 because a stability issue in the buffer prevents the chromogen from developing.

    Product
    Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1523-2016·2016-04-27

    Biocare Medical Recalls Mislabeled Mach 4 Mouse Probe Vials

    Biocare Medical is recalling a single lot of Mach 4 Mouse Probe vials that may be mislabeled as HRP-Polymer.

    Product
    Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0252-2016·2015-11-18

    Biocare Medical Recalls Smooth Muscle Actin Immunohistochemistry Reagents

    Biocare Medical is recalling certain lots of Smooth Muscle Actin reagents because they may stain cell types that should be negative.

    Product
    Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the
    Category
    Medical Device
    Distribution
    23 states
  • LowFDA (Devices)·Z-1676-2015·2015-06-03

    Biocare Medical Recalls D2-40 Lymphatic Marker Due to Incorrect Instructions

    Biocare Medical is recalling 19 units of D2-40 Lymphatic Marker because incorrect Instructions for Use were shipped with the product.

    Product
    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2015·2015-05-06

    Biocare Medical Recalls CD99 In Vitro Diagnostic Reagent Lots

    Biocare Medical is recalling specific lots of CD99 in vitro diagnostic reagents because staining intensity has decreased over time, potentially affecting shelf life.

    Product
    CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0965-2015·2015-01-21

    Biocare Medical Recalls MUM-1 Antibody Lots Due to Staining Intensity Issues

    Biocare Medical is recalling three lots of MUM-1 antibody because staining intensity drops over time, potentially affecting diagnostic accuracy.

    Product
    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein enco
    Category
    Medical Device
    Distribution
    Distributed nationwide