Biocare Medical Llc

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0315-2025Class IIintelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBSeptember 25, 2024
Z-1333-2021Class IIBIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US andFebruary 25, 2021
Z-2291-2020Class II4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, October 10, 2019
Z-2360-2018Class IIVulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline pApril 24, 2018
Z-3198-2018Class IIURO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains cMarch 15, 2018
Z-1523-2016Class IIIMach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For IMarch 31, 2016
Z-0252-2016Class IISmooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B -September 8, 2015
Z-1676-2015Class IIID2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In ViMay 6, 2015
Z-1535-2015Class IICD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive March 17, 2015
Z-0965-2015Class IIMUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro DiagDecember 12, 2014