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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 23 of 36

Device	Model / Reference	Registries	Class	Status
c-Myc	ALI415G7	FDA UDI	Class I	Active
Bcl-6 [LN22]	OPAI410T60	FDA UDI	Class I	Active
4+ Streptavidin AP Label	AP605L	FDA UDI	Class I	Active
Cd23	NPAI100T40	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	ALA3291G7	FDA UDI	Class I	Active
p40 [BC28] BSA Free (1.0mg/ml)	ACC3066CFW	FDA UDI	Class I	Active
DAB Substrate Buffer	DS854H	FDA UDI	Class I	Active
Renoir Red Diluent	PD904L	EUDAMEDFDA UDI	Class I	Active
CD1a [O10]	ACI3158A	FDA UDI	Class I	Active
Borg Decloaker RTU	BD1000S-250	FDA UDI	Class I	Active
Cdx2 [bc39]	ACI3184C	FDA UDI	Class I	Active
Cd44	PM318AA	FDA UDI	Class I	Active
Brca-1	CM345B	FDA UDI	Class I	Active
Napsin A (RM)	ACI3043C	FDA UDI	Class I	Active
L26 + Cd3	PM237DSAA	FDA UDI	Class I	Active
CK5/14 + p63 + CK7/18	PM360DSAA	FDA UDI	Class I	Active
Cdx2	CM226A	FDA UDI	Class I	Active
Progesterone Receptor (PR) [PgR636]	APA343H	FDA UDI	Class II	Active
Cd43	IP005G10	FDA UDI	Class I	Active
Universal Negative Control Serum	NC498H	EUDAMEDFDA UDI	Class I	Active
Ki-67 [MIB-1]	OPAI3156T60	FDA UDI	Class I	Active
p63 + CK5	NPAI391DST40	FDA UDI	Class I	Active
Progesterone Receptor (PR) [16]	ACA424A	FDA UDI	Class I	Active
HMW CK + p63 (Basal Cell Cocktail)	NPAI210T40	FDA UDI	Class I	Active
Cytokeratin 5/6 (CK 5/6)	OPAI105T60	FDA UDI	Class I	Active
Cd8 [c8/144b]	OPAI3160T60	FDA UDI	Class I	Active
Cytokeratin 5 (CK5)	CME430A	FDA UDI	Class I	Active
Napsin A	NPAI434T40	FDA UDI	Class I	Active
Idh1 R132h [ihc132]	ACI3253A	FDA UDI	Class I	Active
Cd68 [kp1]	AVI033G	FDA UDI	Class I	Active
Insm1 [blr272l]	ACI3299A	FDA UDI	Class I	Active
Cd22 [blcam/1796]	API3229AA	FDA UDI	Class I	Active
P504s-2x	PP365JJ	FDA UDI	Class I	Active
Cd34	ALI084G7	FDA UDI	Class I	Active
Cd8 [c8/144b]	ACI3160C	FDA UDI	Class I	Active
CK HMW [34BetaE12]	AVI127G	FDA UDI	Class I	Active
NeoPATH Pro Pepsin	NPRI10030T40	FDA UDI	Class I	Active
Tyrosinase	CM155C	FDA UDI	Class I	Active
Ferangi Blue™ Chromogen Kit 2	FB813S	FDA UDI	Class I	Active
Cytokeratin LMW 8/18	AVI056G	FDA UDI	Class I	Active
Deep Space Black™ Chromogen Kit	BRI4015H	FDA UDI	Class I	Active
Treponema pallidum (Spirochete)	ALA135G7	FDA UDI	Class I	Active
Ki-67	CRM325C	FDA UDI	Class I	Active
CD30 (Ki-1)	CM346B	FDA UDI	Class I	Active
p40 (M)	ACI3066C	FDA UDI	Class I	Active
Msh6	PM265AA	FDA UDI	Class I	Active
Cd3 [bc33]	API3170AA	FDA UDI	Class I	Active
Napsin A (RM)	ACI3043A	FDA UDI	Class I	Active
Pax8	NPAI379T40	FDA UDI	Class I	Active
Myogenin	CM115C	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.