Copan Italia
BRESCIA Lombardy, IT
COPAN ITALIA appears in FDA device records in BRESCIA Lombardy, IT. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Copan Italia between 1997 and 2024. The busiest year on record is 1997, with 2. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 2 |
| 2015 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232565 | UriSponge™ | JSM | Substantially Equivalent | |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | JSM | Substantially Equivalent | |
| K220052 | Copan FecalSwab Collection, Transport and Preservation System | JSM | Substantially Equivalent | |
| K201849 | eNAT molecular collection and preservation medium | QBD | Substantially Equivalent | |
| K180052 | UriSwab-Urine Collection, Transport and Preservation System | JSM | Substantially Equivalent | |
| K142094 | COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM | JSM | Substantially Equivalent | |
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | JSL | Substantially Equivalent | |
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | JSL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002444944 | 3002444944 | COPAN ITALIA | VIA F. PEROTTI, 10, 18, BRESCIA Lombardy 25125 IT | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KXGApplicator, Absorbent Tipped, Sterile
- QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
- KDTContainer, Specimen Mailer And Storage, Sterile
- FMHContainer, Specimen, Sterile
- JSLCulture Media, Anaerobic Transport
- JSMCulture Media, Non-Propagating Transport
- JSGCulture Media, Non-Selective And Non-Differential
- JSJCulture Media, Selective And Non-Differential
- JSDCulture Media, Selective Broth
- JCBDetergent
- LIODevice, Specimen Collection
- MKZDna Probe, Nucleic Acid Amplification, Chlamydia
- LSLDna-Reagents, Neisseria
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- QBDMicrobial Nucleic Acid Storage And Stabilization Device
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- JTWSystem, Transport, Aerobic
- JTXTransport Systems, Anaerobic
- PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0943-2026 | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk | Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed. | Class II | Open, Classified | |
| Z-0942-2026 | 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System | Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. | Class II | Open, Classified | |
| Z-1937-2025 | BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only | Swabs for specimen collection may be prone to breakage during product usage. | Class II | Open, Classified | |
| Z-2440-2021 | COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm; REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm; REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed; REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm; REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm; REF: 519C/519C.BX, Regular Sterile, Molded break point 100 mm; REF: 220250 P/N: 519CS01.BD, Regular, Sterile Single wrapped Molded bp 100mm; REF: 525CS01, Ultra-Thin Minitip, sterile single wrapped, molded bp 80 mm; REF: 528C, Large Tip Swab, Handle with Stopper, in dry tube REF: 534CS01, Flexible Nylon, Sterile Single Wrapped; REF: 551C, Minitip Sterile in dry tube, Molded Break Point 80 mm; REF: 552C/552C.BX, Regular sterile in dry tube Molded Break Point 80 mm; REF: 553C, Flexible sterile in dry tube, molded bp 100 mm; REF: 553C.LC, Flexible Sterile in dry tube, molded bp 100 mm; REF: 5U002S, Regular, sterile, in tube, 80 mm breakpoint, with low stopper; 5U048N01.BIO, REF: 5U055S02.HG, Regular FLOQSwabs with 20mm breakpoint 100 peelpouches, 2 swabs per peelpouch; REF: 5U056S.IUO, FLOQSwats ADULT IN DRY TUBE, Investigational Use Only; REF: 5UO57S.IUO, FLOQSwabs CHILD IN DRY TUBE, Investigational Use Only | 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 II | Terminated | |
| Z-2131-2013 | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes. | 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 of rotation of the broth table when the door is open. | Class III | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain