Facility

MEDICA CORP.

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

Key facts

4recalls · worst Class II

1inspections · worst NAI

—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)	1220972
Establishment type	Repack or Relabel Medical Device
Location	5 OAK PARK DRIVE BEDFORD, MA, US 01730
Registration status	Active · expires 2026
Parent company	MEDICA CORP. (owner-operator 1220972)
Brand names	Buprenorphine (BUN)

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (3)

Calibrators, Drug Specific
Product code DLJ (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3200
Drug Specific Control Materials
Product code LAS (opens in a new tab) · Class I · Clinical Toxicology · 21 CFR 862.3280
Enzyme Immunoassay, Opiates
Product code DJG (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3650

Recalls & enforcement

Class IIOngoing2025-12-31
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Class IITerminated2019-02-06
Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
Class IITerminated2017-11-21
The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover…
Class IITerminated2017-04-11
Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

FDA inspections (1)

NAI2017-04-14
No Action Indicated · Compliance: Devices

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 MEDICA CORP.

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. “MEDICA CORP. (FEI 1220972) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1220972-medica-corp/

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