Facility

COPAN DIAGNOSTICS, INC.

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

Key facts

4recalls · worst Class II

—inspections in our data

—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)	1000521444
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	26055, 26083 & 26087 Jefferson Avenue Murrieta, CA, US 92562
Registration status	Active · expires 2026
Parent company	COPAN ITALIA Spa (owner-operator 9016900)
Brand names	Sputum Dipper; InfoLab Loops; Inoculation Spreaders; BD Inoculation Loops; Inoculation Needles; Dove Medical Supply Loops; Inoculation Loops; Troy Biologicals Loops and Needles; HealthLink Inc. Loops and Needles; Transfer Pipettes; Disposable Transfer Pipettes; Double Spreader

Activity by year

Recalls (4)

Devices registered here (1)

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Product code LXG (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2050

Recalls & enforcement

Class IIOngoing2025-10-29
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Class IIOngoing2025-05-02
Swabs for specimen collection may be prone to breakage during product usage.
Class IITerminated2021-07-09
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
Class IIITerminated2013-08-09
The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has upgraded the software concerning the broth inoculation table feature. The upgrade has been considered necessary from the manufacturer in order to eliminate the very low risk…

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. “COPAN DIAGNOSTICS, INC. (FEI 1000521444) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000521444-copan-diagnostics-inc/

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