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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 31 of 36

Device	Model / Reference	Registries	Class	Status
CK HMW [34BetaE12]	PM127AA	FDA UDI	Class I	Active
Cd10	CM129CK	FDA UDI	Class I	Active
Probe Enhancer (RNA)	BRI6024G10	FDA UDI	Class I	Active
D2-40	CM266A	FDA UDI	Class I	Active
PTEN (Tumor Suppressor)	ALI278G7	FDA UDI	Class I	Active
Lmo2 [sp51]	ACI3262C	FDA UDI	Class I	Active
CD45RO [UCHL-1] BSA Free (1.0mg/ml)	ACC006CF	FDA UDI	Class I	Active
Ck14	CM185B	FDA UDI	Class I	Active
CD117/c-kit	CME296BK	FDA UDI	Class I	Active
Cd54 [e3q9n]	ALI3296G7	FDA UDI	Class I	Active
intelliPATH™ Ferangi Blue™ Chromogen Kit	IPK5027G20	FDA UDI	Class I	Active
Smoothelin	CM372A	FDA UDI	Class I	Active
Cytokeratin 20 (CK20)	CM062C	FDA UDI	Class I	Active
Amacr (rm), 2x	APA3016H	FDA UDI	Class I	Active
Tdt (P)	PP134AA	FDA UDI	Class I	Active
Da Vinci Green Diluent	PD900H	EUDAMEDFDA UDI	Class I	Active
Phospho-Histone H3	PP404AA	FDA UDI	Class I	Active
D2-40	CM266B	FDA UDI	Class I	Active
Nkx3.1 [d2y1a]	ACI3260B	FDA UDI	Class I	Active
Rabbit Amp AP Detection	OPRI6086T60	EUDAMEDFDA UDI	Class I	Active
Synaptophysin	CM371CK	FDA UDI	Class I	Active
HPV Type 16 Probe (Digoxigenin)	BRA4047-0.6	FDA UDI	Class I	Active
Pan Melanoma Cocktail-2	AVI178G	FDA UDI	Class I	Active
Ttf-1	CM087A	FDA UDI	Class I	Active
Cd137 [blr051f]	ACI3264C	FDA UDI	Class I	Active
Tubing Cleaning Kit	OPRI6036KC3	FDA UDI	Class I	Active
Ae1/Ae3 + 8/18	CM162A	FDA UDI	Class I	Active
Uro-2™ (CK20 + p53)	API3001DSAA	FDA UDI	Class I	Active
Uroplakin III	ACI3023A	FDA UDI	Class I	Active
E-Cadherin [CDH1/2208R]	API3230AA	FDA UDI	Class I	Active
Calretinin	PP092AA	FDA UDI	Class I	Active
TTF-1 + Napsin A (RM)	API3078DSAA	FDA UDI	Class I	Active
intelliPATH Plus	IPPLS0001INTL-R	FDA UDI	Class I	Active
Ki-67 [mib-1]	ALI3156G25	FDA UDI	Class I	Active
Ki-67	PRM325AA	FDA UDI	Class I	Active
RISH™ EBER Probe	BRA0001T	FDA UDI	Class I	Active
NeoPATH Pro Universal AP Polymer Kit	NPRI10027KT135	FDA UDI	Class I	Active
S100p	ACI3010A	FDA UDI	Class I	Active
Cd19 (rm) [rm332]	ACI3270C	FDA UDI	Class I	Active
Pan Cytokeratin [AE1/AE3]	OPAI011T60	FDA UDI	Class I	Active
Hhv-8 [13b10]	AVA3290G	FDA UDI	Class I	Active
Cd23	CM100C	FDA UDI	Class I	Active
Cd47 [epr21794]	AVI3284G	FDA UDI	Class I	Active
Estrogen Receptor (ER) [1D5]	APA054AA	FDA UDI	Class II	Active
Satb2 [cl0323]	API3259AA	FDA UDI	Class I	Active
Sox10 (m)	ALI3099G7	FDA UDI	Class I	Active
Pd-1 [cal20]	ACI3224B	FDA UDI	Class I	Active
HPV Type 31 Probe (Digoxigenin)	BRA4051A	FDA UDI	Class I	Active
Helicobacter pylori	PM383AA	FDA UDI	Class I	Active
p120 Catenin	NPAI3008T40	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.