Home / Brands / Biocare Medical
Biocare Medical Recalls
10 recalls on record · January 21, 2015 to November 13, 2024 · Medical Devices
Recalls by year
15
16
18
20
21
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 13, 2024Medical DevicesFDA
Biocare Medical, LLC recalls intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE P
Hazard: 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.
April 7, 2021Medical DevicesFDA
Biocare Medical, LLC recalls BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL contain
Hazard: 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.
June 17, 2020Medical DevicesFDA
Biocare Medical, LLC recalls 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP60
Hazard: 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.
September 26, 2018Medical DevicesFDA
Biocare Medical, LLC recalls URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 +
Hazard: Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
July 11, 2018Medical DevicesFDA
Biocare Medical, LLC recalls Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) dete
Hazard: Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
April 27, 2016Medical DevicesFDA
Biocare Medical, LLC recalls Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immun
Hazard: 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.
November 18, 2015Medical DevicesFDA
Biocare Medical, LLC recalls Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA -
Hazard: Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
June 3, 2015Medical DevicesFDA
Biocare Medical, LLC recalls D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.:
Hazard: Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
May 6, 2015Medical DevicesFDA
Biocare Medical, LLC recalls CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic informati
Hazard: A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
January 21, 2015Medical DevicesFDA
Biocare Medical Llc recalls MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This ant
Hazard: Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.