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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 14 of 36

Device	Model / Reference	Registries	Class	Status
Topoisomerase II alpha	ACI3045B	FDA UDI	Class I	Active
Estrogen Receptor (ER) [1D5]	API054AA	FDA UDI	Class II	Active
MACH 2 Double Stain 1	MRCT523H	EUDAMEDFDA UDI	Class I	Active
P504s (p)	OPAI200T60	FDA UDI	Class I	Active
Hairy Cell Leukemia [DBA.44]	OPAI3279T60	FDA UDI	Class I	Active
Ttf-1 [spt24]	API3126AA	FDA UDI	Class I	Active
Ae1/Ae3+8/18	AVI162G	FDA UDI	Class I	Active
Decloaking Chamber™ NxGen	DC2012	FDA UDI	Class I	Active
Copy Control 12 Aqua	HFA7211A	FDA UDI	Class I	Active
Mum-1	CRM352A	FDA UDI	Class I	Active
c-Myc	PME415AA	FDA UDI	Class I	Active
Sox11 (m)	ACI3120C	FDA UDI	Class I	Active
Leukocyte Common Antigen (LCA) Cocktail	NPAI016T40	FDA UDI	Class I	Active
Sox10 (m)	NPAI3099T40	FDA UDI	Class I	Active
Pan Cytokeratin Plus [AE1/AE3+8/18]	OPAI162T60	FDA UDI	Class I	Active
Pan Cytokeratin [AE1/AE3]	NPAI011T80	FDA UDI	Class I	Active
Pd-L1	AVI3171G	FDA UDI	Class I	Active
intelliPATH MAX	IPMX0001US	FDA UDI	Class I	Active
MACH 2 Universal HRP Polymer Detection	M2U522L	EUDAMEDFDA UDI	Class I	Active
Pan Melanoma + Ki-67	PM362DSAA	FDA UDI	Class I	Active
Hhv-8 [13b10]	ACA3290A	FDA UDI	Class I	Active
Cd57	CM007B	FDA UDI	Class I	Active
p16 + Ki-67	OPAI3246DST60	FDA UDI	Class I	Active
Hmb45	CM057B	FDA UDI	Class I	Active
Factor XIIIa	CM357AK	FDA UDI	Class I	Active
Starr Trek Universal HRP Detection	STUHRP700H-KIT	FDA UDI	Class I	Active
Atrx	AVI3251G	FDA UDI	Class I	Active
Pax8 (m)	API438H	FDA UDI	Class I	Active
Ca 19-9	PM123AA	FDA UDI	Class I	Active
c-erbB-2/HER2	ACA342B	FDA UDI	Class I	Active
5p15.2 Red	PFA7251V	FDA UDI	Class I	Active
Mlh-1	PM220H	FDA UDI	Class I	Active
CK5/14 + p63 + P504S	API225DSAA	FDA UDI	Class I	Active
Sox10 (m)	NPAI3099T80	FDA UDI	Class I	Active
Pax5	CM207A	FDA UDI	Class I	Active
Glypican-3	NPAI396T40	FDA UDI	Class I	Active
Calcitonin	CP072B	FDA UDI	Class I	Active
Polymer Negative Control Serum (Mouse & Rabbit)	NC499H	FDA UDI	Class I	Active
Alk [5a4]	API3041AA	FDA UDI	Class I	Active
intelliPATH MAX	IPMX0001INTL-R	FDA UDI	Class I	Active
Msh2	NPAI219T80	FDA UDI	Class I	Active
Cd20 [l26]	NPAI004T40	FDA UDI	Class I	Active
Cd20 [l26]	ALI004G7	FDA UDI	Class I	Active
Gfap (m)	CM065C	FDA UDI	Class I	Active
Vimentin	CM048C	FDA UDI	Class I	Active
RISH™ Lambda Light Chain DNA Probe	BRA0005T	FDA UDI	Class I	Active
CD11c (Leu-M5)	API3122AA	FDA UDI	Class I	Active
CD30 (Ki-1)	PM346AA	FDA UDI	Class I	Active
Thyroglobulin Cocktail	PM022AA	FDA UDI	Class I	Active
Factor XIIIa	CM357CK	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

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Notified Bodies

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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.