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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 6 of 36

Device	Model / Reference	Registries	Class	Status
Nkx3.1 [d2y1a]	ALI3260G7	FDA UDI	Class I	Active
DS Enzyme Kit	OPRI6060KT60	EUDAMEDFDA UDI	Class I	Active
Hla-B [bc43]	ACI3289C	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	APA3291AA	FDA UDI	Class I	Active
Stag1	OPAI3250T60	FDA UDI	Class I	Active
Mlh-1	OPAI220T60	FDA UDI	Class I	Active
Cd20 [l26]	IP004G20	FDA UDI	Class I	Active
p16 INK4a [BC42]	API3231AA	FDA UDI	Class I	Active
Melan A (M)	API3114H	FDA UDI	Class I	Active
HPV Type 6 Probe (Digoxigenin)	BRA4045-0.6	FDA UDI	Class I	Active
Cd3	CME324B	FDA UDI	Class I	Active
Mouse HRP Detection	OPRI6007T60	FDA UDI	Class I	Active
Arginase-1	AVI3058G	FDA UDI	Class I	Active
Glycophorin A [JC159]	ACI3272C	FDA UDI	Class I	Active
Cd56	CM164A	FDA UDI	Class I	Active
RB1 (13q14.2) Orange	HFA7298A	FDA UDI	Class I	Active
CK HMW + p63 + AMACR (RM)	NPAI3154DST80	FDA UDI	Class I	Active
Copy Control 7 Orange	CFA7187A	FDA UDI	Class I	Active
5p15.2 Red	CFA7251X	FDA UDI	Class I	Active
Melan A	ALI3114G7	FDA UDI	Class I	Active
Cd44	CM318B	FDA UDI	Class I	Active
P504s (p)	OPAA200T60	FDA UDI	Class I	Active
Cd21	CM142A	FDA UDI	Class I	Active
MACH 4 Universal HRP Polymer	M4U534MM	FDA UDI	Class I	Active
Plap	CRM350C	FDA UDI	Class I	Active
p53	AVI298G	FDA UDI	Class I	Active
Napsin A	CM388AK	FDA UDI	Class I	Active
Sall4	PM384AA	FDA UDI	Class I	Active
Human IgG	API3185AA	FDA UDI	Class I	Active
PSAP [rACPP/1338]	ACI3263C	FDA UDI	Class I	Active
Pax8	CP379AK	FDA UDI	Class I	Active
p53	NPAI042T40	FDA UDI	Class I	Active
Cd20 [bc30]	ALI3287G7	FDA UDI	Class I	Active
HER2/neu [IHC042]	ALA3274G7	FDA UDI	Class I	Active
p63, 2X (Lung)	API3070AA	FDA UDI	Class I	Active
p120 + E-cadherin	API3011DSAA	FDA UDI	Class I	Active
p63 + TRIM29	PPM427DSAA	FDA UDI	Class I	Active
Sox11 (m)	API3120AA	FDA UDI	Class I	Active
Spirochete	ACI135C	FDA UDI	N	Active
ATM (11q22.3) Orange	HFA7262A	FDA UDI	Class I	Active
HPV Type 16 Probe (Digoxigenin)	BPA4047T60	FDA UDI	Class I	Active
Hsv 1 & 2	API108AA	FDA UDI	Class I	Active
Synaptophysin	CM371AK	FDA UDI	Class I	Active
1q21.3 Orange	HFA7308A	FDA UDI	Class I	Active
S100p	API3010AA	FDA UDI	Class I	Active
Multiplex Detection 2	OPRI6045T60	FDA UDI	Class I	Active
RISH™ HRP Detection Kit	RI0207KG	FDA UDI	Class I	Active
Cd20 [bc30]	API3287AA	FDA UDI	Class I	Active
MACH 2 Universal HRP Polymer Detection	M2U522G	EUDAMEDFDA UDI	Class I	Active
CK HMW + p63 + AMACR (RM)	API3154DSL	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.