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BIOCARE MEDICAL, LLC

United States·US-MF-000034581

Last updated September 17, 2026

Information

Country: United States
Address: 60, Berry Drive, Pacheco, United States
Website: www.biocaremedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1(855) 504-9997
PRRC Contact: Pia Carusi
EUDAMED SRN: US-MF-000034581
FDA FEI Number: 3004140393
DUNS Number: —

Catalogue (1765)

Page 13 of 36

Device	Model / Reference	Registries	Class	Status
Cd4 (rm)	API3209AA	FDA UDI	Class I	Active
Nkx3.1 [d2y1a]	API3260AA	FDA UDI	Class I	Active
Cdx2	NPAI226T80	FDA UDI	Class I	Active
Pms2	OPAI344T60	FDA UDI	Class I	Active
Claudin-4	ALI3121G7	FDA UDI	Class I	Active
Pms2	AVI344G	FDA UDI	Class I	Active
ONCORE Pro RISH™ Retrieval Kit	OPRI6082K	FDA UDI	Class I	Active
Mast Cell Tryptase [AA1]	AVI3277G	FDA UDI	Class I	Active
Stat6 [ye361]	OPAI3244T60	FDA UDI	Class I	Active
Revival Series Sampler	PD912H4	EUDAMEDFDA UDI	Class I	Active
Lambda Light Chain [N10/2]	ACI3063A	FDA UDI	Class I	Active
Cd34	OPAI084T60	FDA UDI	Class I	Active
p16 + PRAME	API3256DSAA	FDA UDI	Class I	Active
Pan Cytokeratin [AE1/AE3]	IPI011G10	FDA UDI	Class I	Active
Calretinin	OPAI092T60	FDA UDI	Class I	Active
Cd19 (rm) [rm332]	AVI3270G	FDA UDI	Class I	Active
Microphthalmia Transcription Factor (MiTF)	OPAI423T60	FDA UDI	Class I	Active
p27 KIP1 [Y236]	ACI3282C	FDA UDI	Class I	Active
Hairy Cell Leukemia [DBA.44]	API3279AA	FDA UDI	Class I	Active
E-cadherin	AVI170G	FDA UDI	Class I	Active
Background Sniper	BS966H	FDA UDI	Class I	Active
Human IgG	ACI3185B	FDA UDI	Class I	Active
Hairy Cell Leukemia [DBA.44]	ACI3279B	FDA UDI	Class I	Active
Pms2	PM344AA	FDA UDI	Class I	Active
Mash1	ACI3131A	FDA UDI	Class I	Active
MACH 2 Rabbit AP-Polymer	RALP525H	EUDAMEDFDA UDI	Class I	Active
EMA [Mc-5]	PM143AA	FDA UDI	Class I	Active
Treponema pallidum (Spirochete)	ACA135B	FDA UDI	Class I	Active
p40 (M) [BC28]	NPAI3066T40	FDA UDI	Class I	Active
Ki-67	OPAI325T60	FDA UDI	Class I	Active
Leukocyte Common Antigen (LCA) Cocktail	ALI016G7	FDA UDI	Class I	Active
FGFR3 (4p16.3) Aqua	HFA7276A	FDA UDI	Class I	Active
Progesterone Receptor (PR) [16]	NPAA424T40	FDA UDI	Class II	Active
Helicobacter pylori	CM383A	FDA UDI	Class I	Active
p16 INK4a [BC42]	ACI3231A	FDA UDI	Class I	Active
Dewax Solution 1, DS1	OPRI6001KT60	FDA UDI	Class I	Active
Cd10	ALI129G7	FDA UDI	Class I	Active
Msh6	CM265AK	FDA UDI	Class I	Active
Chromogranin A	ALI010G7	FDA UDI	Class I	Active
Lag3 [cal26]	ACI3213B	FDA UDI	Class I	Active
Tyrosinase	CM155B	FDA UDI	Class I	Active
Beta-Catenin	CM406A	FDA UDI	Class I	Active
Ca-9	API3285AA	FDA UDI	Class I	Active
Cd34	NPAI084T40	FDA UDI	Class I	Active
Bcl-2	CM003A	FDA UDI	Class I	Active
CK HMW [34BetaE12]	CM127A	FDA UDI	Class I	Active
Msh2	PM219H	FDA UDI	Class I	Active
Sma	PM001AA	FDA UDI	Class I	Active
Nkx3.1	AVI422G	FDA UDI	Class I	Active
Antigen Retrieval 1 (AR1), high pH	OPRI6006T60	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

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Authorities

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FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 25, 2024	Z-0315-2025	—	open, classified	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.
Feb 25, 2021	Z-1333-2021	—	terminated	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.
Oct 10, 2019	Z-2291-2020	—	terminated	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.
Apr 24, 2018	Z-2360-2018	—	terminated	Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
Mar 15, 2018	Z-3198-2018	—	terminated	Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Mar 31, 2016	Z-1523-2016	—	terminated	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.
Sep 8, 2015	Z-0252-2016	—	terminated	Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.
May 6, 2015	Z-1676-2015	—	terminated	Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Mar 17, 2015	Z-1535-2015	—	terminated	A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Dec 12, 2014	Z-0965-2015	—	terminated	Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
Mar 13, 2012	Z-1392-2012	—	terminated	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.