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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 17 of 36

Device	Model / Reference	Registries	Class	Status
Ck Lmw 8/18	CM056A	FDA UDI	Class I	Active
Cd31 (pecam-1)	CM131A	FDA UDI	Class I	Active
Cytokeratin 20 (CK20)	NPAI062T40	FDA UDI	Class I	Active
Pan Melanoma Cocktail-2	CM178A	FDA UDI	Class I	Active
Sox10 (m)	AVI3099G	FDA UDI	Class I	Active
Cd56	PM164AA	FDA UDI	Class I	Active
Pd-1	ACI3137AK	FDA UDI	Class I	Active
Pan TRK [RM423]	ALI3267G7	FDA UDI	Class I	Active
Ki-67	NPAI325T40	FDA UDI	Class I	Active
Ck5	PM234AA	FDA UDI	Class I	Active
Ber-EP4	PM107H	FDA UDI	Class I	Active
Cd247 [bl-336-1b2]	API3268AA	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	ALA3291G25	FDA UDI	Class I	Active
Ido1	ACI3210A	FDA UDI	Class I	Active
Oct 3/4 [n1nk]	API3278AA	FDA UDI	Class I	Active
Ttf-1	PM087AA	FDA UDI	Class I	Active
Msh6 [bc19]	API3215H	FDA UDI	Class I	Active
Mesothelin	ACI3175A	FDA UDI	Class I	Active
Calretinin	CP092C	FDA UDI	Class I	Active
ARCHV – Antigen Retrieval Chamber High Voltage	DCARC0003	FDA UDI	Class I	Active
Neurofilament	CM066A	FDA UDI	Class I	Active
P504s (p)	NPAA200T40	FDA UDI	Class I	Active
Background Punisher	BP974M	FDA UDI	Class I	Active
Lambda Light Chain [N10/2]	ACI3063C	FDA UDI	Class I	Active
p40 (M)	AVI3066KH	FDA UDI	Class I	Active
Cytokeratin LMW (8/18)	NPAI056T40	FDA UDI	Class I	Active
Treponema pallidum (Spirochete)	NPAA135T40	FDA UDI	Class I	Active
Nkx3.1 [d2y1a]	AVI3260G	FDA UDI	Class I	Active
Prostate Cocktail-2X (CK5 + CK14 + p63)	PM364AAK	FDA UDI	Class I	Active
p40 (M)	API3066H	FDA UDI	Class I	Active
Nkx3.1	ALI422G7	FDA UDI	Class I	Active
Cd20 [bc30]	ACI3287C	FDA UDI	Class I	Active
Cd8	PRM311AA	FDA UDI	Class I	Active
Lag3 [cal26]	ACI3213A	FDA UDI	Class I	Active
Mum-1	ALI352G7	FDA UDI	Class I	Active
CD3 T-Cell	PM110L	FDA UDI	Class I	Active
S100 Protein [4C4.9] (M)	ALI3237G7	FDA UDI	Class I	Active
Moc-31	CM403C	FDA UDI	Class I	Active
Msh2	CM219BK	FDA UDI	Class I	Active
p63-2X	PM366HK	FDA UDI	Class I	Active
Ae1/Ae3 + 8/18	CM162C	FDA UDI	Class I	Active
Cd3 [bc33]	NPAI3170T40	FDA UDI	Class I	Active
Npm1	API3281AA	FDA UDI	Class I	Active
Cd33	ACI3116C	FDA UDI	Class I	Active
P504s (amacr) (rm) [13h4]	AVA3207G	FDA UDI	Class I	Active
Pan Cytokeratin [AE1/AE3]	CM011A	FDA UDI	Class I	Active
WT1 [rWT1/857]	ACI3238C	FDA UDI	Class I	Active
Napsin A	PM388AA	FDA UDI	Class I	Active
Ber-EP4	OPAI107T60	FDA UDI	Class I	Active
Insm1 [blr272l]	API3299AA	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.