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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 1 of 36

Device	Model / Reference	Registries	Class	Status
Chromogranin A	IP010G10	FDA UDI	Class I	Active
Cd20 [l26]	NPAI004T80	FDA UDI	Class I	Active
Peroxidazed 1	PX968H	FDA UDI	Class I	Active
Msh2	CM219AK	FDA UDI	Class I	Active
Cd19 (rm) [rm332]	ALI3270G7	FDA UDI	Class I	Active
p16 INK4a [BC42]	OPAI3231T60	FDA UDI	Class I	Active
LCA Cocktail	CM016AK	FDA UDI	Class I	Active
Moc-31	ALI403G7	FDA UDI	Class I	Active
Insm1 [blr272l]	OPAI3299T60	FDA UDI	Class I	Active
Afp	CP028A	FDA UDI	Class I	Active
intelliPATH FLX™ Universal HRP Detection Kit, 80 - 100 tests	IPK5003G20	FDA UDI	Class I	Active
Mlh-1	IPI220G10	FDA UDI	Class I	Active
Chromogranin A	NPAI010T40	FDA UDI	Class I	Active
Sox10 (m)	OPAI3099T60	FDA UDI	Class I	Active
CD117/c-kit	OPAI296T60	FDA UDI	Class I	Active
Progesterone Receptor [PgR636]	IPA343G10	FDA UDI	Class II	Active
MACH 2 Double Stain 1	MRCT523L	EUDAMEDFDA UDI	Class I	Active
Gata-3	OPAI405T60	FDA UDI	Class I	Active
Desmoglein 3	PM419AA	FDA UDI	Class I	Active
Cd31	CM303B	FDA UDI	Class I	Active
Epstein-Barr Virus (EBV)	API111AA	FDA UDI	Class I	Active
intelliPATH FLX™ Fast Red Chromogen Kit	IPK5017G80	EUDAMEDFDA UDI	Class I	Active
Ctla-4 [cal49]	ACI3220A	FDA UDI	Class I	Active
Cytokeratin 5/6 (CK 5/6)	AVI105G	FDA UDI	Class I	Active
Pax5	CM207C	FDA UDI	Class I	Active
Cd19 (rm) [rm332]	API3270AA	FDA UDI	Class I	Active
HMB45 + MART-1 + Tyrosinase	OPAI165T60	FDA UDI	Class I	Active
HPV Type 11 Probe (Digoxigenin)	BPA4046T60	FDA UDI	Class I	Active
Cd68 [kp1]	OPAI033T60	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	OPAA301T60	FDA UDI	Class II	Active
Estrogen Receptor (ER) [SP1]	ACA301B	FDA UDI	Class I	Active
Cytokeratin LMW (8/18)	IPI056G10	FDA UDI	Class I	Active
c-erbB-2/HER2	APA342AA	FDA UDI	Class I	Active
Hmb45	AVI057G	FDA UDI	Class I	Active
Chromogranin A	CM010A	FDA UDI	Class I	Active
Pan Cytokeratin Plus [AE1/AE3 + 8/18]	API3227H	FDA UDI	Class I	Active
Cd20 [bc30]	AVI3287G	FDA UDI	Class I	Active
Cd47 [epr21794]	OPAI3284T60	FDA UDI	Class I	Active
ROR gamma T	ACI3208A	FDA UDI	Class I	Active
MACH 2 Double Stain 1	MRCT523G	FDA UDI	Class I	Active
MACH 2 Universal HRP Polymer Detection	M2U522H	EUDAMEDFDA UDI	Class I	Active
Cd3 (p)	CP215C	FDA UDI	Class I	Active
E-cadherin	IP170G10	FDA UDI	Class I	Active
Tigit [bc41]	ACI3254A	FDA UDI	Class I	Active
HMW CK + p63	CM210C	FDA UDI	Class I	Active
Cd3	CME324C	FDA UDI	Class I	Active
Bap1	ALI3247G7	FDA UDI	Class I	Active
MACH 2 Mouse AP-Polymer	MALP521L	EUDAMEDFDA UDI	Class I	Active
Gata-3	CM405B	FDA UDI	Class I	Active
Pan TRK [RM423]	AVI3267G	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

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.