Is this your brand? Sign in to claim ownership.

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 30 of 36

Device	Model / Reference	Registries	Class	Status
Cd247 [bl-336-1b2]	ACI3268A	FDA UDI	Class I	Active
CD3 T-Cell (M)	OPAI110T60	FDA UDI	Class I	Active
Napsin A	NPAI388T40	FDA UDI	Class I	Active
Cytokeratin HMW [34BE12]	IPI127G10	FDA UDI	Class I	Active
Ae1/Ae3 + 8/18	PM162AA	FDA UDI	Class I	Active
Cd68 [kp1]	PM033AA	FDA UDI	Class I	Active
Melan A (M)	AVI3114G25	FDA UDI	Class I	Active
Msh2	NPAI219T40	FDA UDI	Class I	Active
Ck Lmw 8/18	CM056C	FDA UDI	Class I	Active
Msh6 [bc19]	API3215AA	FDA UDI	Class I	Active
Ck [ae1] Lmw	PM081AA	FDA UDI	Class I	Active
Vulcan Fast Red Chromogen Kit 2	FR805S	EUDAMEDFDA UDI	Class I	Active
Cd68 [kp1]	CM033C	FDA UDI	Class I	Active
Hepatocyte Specific Antigen (HSA)	CM166A	FDA UDI	Class I	Active
Tim3 [blr033f]	API3258AA	FDA UDI	Class I	Active
Prame [epr20330]	AVI3252G25	EUDAMEDFDA UDI	Class I	Active
Vista [blr035f]	API3271AA	FDA UDI	Class I	Active
MACH 4 Universal HRP-Polymer Detection System	BRI4012L	EUDAMEDFDA UDI	Class I	Active
CK5 + p63	PM235AA	FDA UDI	Class I	Active
Stat6 [ye361]	ACI3244A	FDA UDI	Class I	Active
p63 + CK5	PM391DSAA	FDA UDI	Class I	Active
Sox10 (m)	ACI3099C	FDA UDI	Class I	Active
Copy Control 4q12 Green	HFA7168A	FDA UDI	Class I	Active
HPV Type 18 Probe (Digoxigenin)	BRA4048A	FDA UDI	Class I	Active
Pcna [pc10]	AVI3255G	FDA UDI	Class I	Active
p40 (M)	ALI3066G7	FDA UDI	Class I	Active
GATA-3 + Uroplakin II	AVI3173G	FDA UDI	Class I	Active
Ck7	CRM339C	FDA UDI	Class I	Active
4+ HRP Universal Detection	HP504US	EUDAMEDFDA UDI	Class I	Active
Treponema pallidium (Spirochete)	IPA135G10	FDA UDI	Class I	Active
Kappa Light Chain [L1C1]	ACI3149A	FDA UDI	Class I	Active
Hot Rinse 25X	HTR1001M	EUDAMEDFDA UDI	Class I	Active
Cd3 (m)	PM110AA	FDA UDI	Class I	Active
Progesterone Receptor (PR) [SP2]	API302AA	FDA UDI	Class I	Active
ONCORE Pro DAB Chromogen	OPRI6056KT180	EUDAMEDFDA UDI	Class I	Active
Immunocare PBS 10X	PWB941M	FDA UDI	Class I	Active
Bcl-6 [LN22]	PM410AA	FDA UDI	Class I	Active
Ck 5/6	PM105AA	FDA UDI	Class I	Active
Nuclear Decloaker 10X	CB911M	EUDAMEDFDA UDI	Class I	Active
PeroxAbolish	PXA969M	FDA UDI	Class I	Active
Ki-67 [MIB-1]	API3156AA	FDA UDI	Class I	Active
Human IgG	ACI3185A	FDA UDI	Class I	Active
CD11c (Leu-M5)	ACI3122B	FDA UDI	Class I	Active
Trbc1	AVI3280G	FDA UDI	Class I	Active
Smooth Muscle Myosin Heavy Chain	NPAI420T40	FDA UDI	Class I	Active
Pan Cytokeratin [Lu-5]	IP043G10	FDA UDI	Class I	Active
Pan TRK [RM423]	API3267AA	FDA UDI	Class I	Active
MACH 3 Rabbit HRP Polymer Detection	M3R531H	EUDAMEDFDA UDI	Class I	Active
Avidin Biotin Kit	AB972H	EUDAMEDFDA UDI	Class I	Active
Carezyme I: Trypsin Kit	TRP955KH	EUDAMEDFDA 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.