Biocare Medical LLC
Pacheco, CA, US
BIOCARE MEDICAL, LLC appears in FDA device records in Pacheco, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004140393 | 3004140393 | BIOCARE MEDICAL, LLC | 60 Berry Drive, Pacheco, CA 94553 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KESCoverslips, Microscope Slide
- HYBEosin Y
- LSEEpstein-Barr Virus, Other
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- HYJHematoxylin
- MYAImmunohistochemistry Antibody Assay, Estrogen Receptor
- MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor
- NJTImmunohistochemistry Reagents And Kits
- LEBMounting Media
- JCCPh Buffer
- MVUReagents, Specific, Analyte
- KPASlide Stainer, Automated
- MVCSystem, Test, Her-2/Neu, Ihc
- MTNTest, Syphilis, Treponemal
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0315-2025 | 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, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20 | Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated. | Class II | Open, Classified | |
| Z-1333-2021 | BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 | Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations. | Class II | Terminated | |
| Z-2291-2020 | 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H | Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis. | Class II | Terminated | |
| Z-2360-2018 | 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 | Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer. | Class II | Terminated | |
| Z-3198-2018 | 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 CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues, primarily for bladder cancer characterization. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient s clinical history and other diagnostic tests by a qualified pathologist. The URO-3 Triple Stain is an adjunct immunohistochemistry test to assist a qualified pathologist in differentiating urothelial reactive atypia from CIS (carcinoma in situ) in suspected bladder lesions. The URO-3 staining pattern will be used as supporting data along with morphological and patient history context for the qualified pathologist to render a diagnosis. | Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components. | Class II | Terminated | |
| Z-1523-2016 | 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 rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. | Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer. | Class III | Terminated | |
| Z-0252-2016 | 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 alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells. | Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA. | Class II | Terminated | |
| Z-1676-2015 | 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 (ICH) in formalin fixed paraffin embedded human tissues. | Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. | Class III | Terminated | |
| Z-1535-2015 | 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. | A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life. | Class II | Terminated | |
| Z-0965-2015 | 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 encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation. | Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed. | Class II | Terminated | |
| Z-1392-2012 | BioCare Medical Vina Green Chromogen Kit; 25 mL, 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer, 25 mL and Vina Green Dropper Bottle. BioCare Medical, Concord, CA 94520. Vina Green is intended for both IHC and ISH applications including HPV, CMV, EBV, Kappa, TTF-1, Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells. | Reports of sporadic failure of specific lots of Vina Green Chromogen Kit, either through crystal formation that obscures positive staining, color not right, or a complete fading of staining by the chromogen. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain