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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 5 of 36

Device	Model / Reference	Registries	Class	Status
RISH™ Lambda Light Chain DNA Probe	OPPA0005T60	FDA UDI	Class I	Active
Helicobacter pylori [EPR10353]	OPAA3291T60	FDA UDI	Class I	Active
p63	VP163G25	FDA UDI	Class I	Active
Estrogen Receptor (ER) [SP1]	APA301H	FDA UDI	Class II	Active
Cyclin D1	CME432A	FDA UDI	Class I	Active
Nerve Growth Factor Receptor (NGFR)	ACI369A	FDA UDI	Class I	Active
E-Cadherin (RM)	ACI3012C	FDA UDI	Class I	Active
Prame [epr20330]	NPAI3252T40	FDA UDI	Class I	Active
Mcm2+top2a	OPAI3181T60	FDA UDI	Class I	Active
Ros1 [epmghr2]	API3240AA	FDA UDI	Class I	Active
Ki-67	ALI325G7	FDA UDI	Class I	Active
Glutamine Synthetase	API3009AA	FDA UDI	Class I	Active
p63	VP163G	FDA UDI	Class I	Active
Ck 5/6	CM105B	FDA UDI	Class I	Active
Cd3 [ln10]	API3152AA	FDA UDI	Class I	Active
Sox10 (m)	AVI3099H	FDA UDI	Class I	Active
Cd54 [e3q9n]	ACI3296A	FDA UDI	Class I	Active
MACH 3 Rabbit AP Polymer Detection	M3R533G	EUDAMEDFDA UDI	Class I	Active
Ae1/Ae3 + 8/18	CM162B	FDA UDI	Class I	Active
Mcm2 + Top2a	API3181AA	FDA UDI	Class I	Active
Amacr (rm)	APA3024AA	FDA UDI	Class I	Active
Carezyme II: Pepsin	PEP956L	EUDAMEDFDA UDI	Class I	Active
Smooth Muscle Actin (SMA)	IP001G10	FDA UDI	Class I	Active
Cytokeratin 20 (CK20)	NPAI062T80	FDA UDI	Class I	Active
Mesothelin	API3175AA	FDA UDI	Class I	Active
CCND1 (11q13) Orange	HFA7260A	FDA UDI	Class I	Active
Npm1	AVI3281G	FDA UDI	Class I	Active
Pan Cytokeratin Plus [AE1/AE3 + 8/18]	ACI3227C	FDA UDI	Class I	Active
Vulcan Fast Red Chromogen Kit 2	FR805H	FDA UDI	Class I	Active
Estrogen Receptor (ER) [1D5]	OPAA054T60	FDA UDI	Class I	Active
Smoothelin	CM372C	FDA UDI	Class I	Active
Ber-EP4	PM107AA	FDA UDI	Class I	Active
Tle 1 [epr9386(2)]	AVI3301G	FDA UDI	Class I	Active
Ca 125	PM101AA	FDA UDI	Class I	Active
Cd8 [c8/1779r]	ACI3219A	FDA UDI	Class I	Active
CK HMW + p63 + AMACR (RM)	IPI3154DSG10	FDA UDI	Class I	Active
Topoisomerase II alpha	ACI3045A	FDA UDI	Class I	Active
Cd45ro [uchl-1]	CM006B	FDA UDI	Class I	Active
Cd4 + Cd8	API3157DSAA	FDA UDI	Class I	Active
S100p	ACI3010B	FDA UDI	Class I	Active
Estrogen Receptor (ER) [1D5]	ACA054C	FDA UDI	Class II	Active
Napsin A	PM388H	FDA UDI	Class I	Active
CD117/c-kit	NPAI296T40	FDA UDI	Class I	Active
HPV Type 11 Probe (Digoxigenin)	BRA4046-0.6	FDA UDI	Class I	Active
Ifng [ifng/3996r]	API3266AA	FDA UDI	Class I	Active
Reveal Decloaker RTU	RV1000MMRTU	EUDAMEDFDA UDI	Class I	Active
Leukocyte Common Antigen (LCA) Cocktail	NPAI016T80	FDA UDI	Class I	Active
Gata-3	NPAI405T80	FDA UDI	Class I	Active
intelliPATH MAX	IPMX0001INTL	FDA UDI	Class I	Active
Universal Negative Control Serum	OPRI6013T60	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.