Facility

ASSOCIATES OF CAPE COD, INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1219145
Establishment type	Manufacture Medical Device
Location	124 Bernard E. Saint Jean Drive E Falmouth, MA, US 02536
Registration status	Active · expires 2026
Parent company	ASSOCIATES OF CAPE COD, INC. (owner-operator 1219145)
Brand names	BG Analytics

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Calculator/Data Processing Module, For Clinical Use
Product code JQP (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2100

Recalls & enforcement

Class IITerminated2022-08-17
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Class IITerminated2018-12-19
The kits may contain the incorrect number of components or the kits may be missing components.

FDA inspections (1)

NAI2021-10-21
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by ASSOCIATES OF CAPE COD, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ASSOCIATES OF CAPE COD, INC. (FEI 1219145) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1219145-associates-of-cape-cod-inc/

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