CLASS III Device recall · Reported 11 Sep 2013 · FDA Enforcement Report
WASP (Walk Away Specimen Process) recalled by Copan Italia
Copan Italia is recalling WASP (Walk Away Specimen Process), distributed in California, Oregon. The recall was initiated on 9 Aug 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2131-2013
- FDA event ID
- 65923
- Recalling firm
- Copan Italia, Brescia, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Aug 2013
- FDA classified
- 30 Aug 2013
- Reported
- 11 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 9 Aug 2013 | Recall initiated by company | |
| 30 Aug 2013 | Classified by FDA | +21 days |
| 11 Sep 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA including Oregon and California., and the countries of France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: W086-61-084/106/115/119/134/136; W086-050-179; W086-61-087/109/125/127/130/133; W086-050-144/151/153/157/170/171/181/184; W086-61-088/097/100/117; W086-050-177/178/183; W086-61-093; W086-050-143/155; W086-61-096; W086-050-164/169/159/175; W086-61-103/137/141/142; W08661-104/114118/128/138; W086050-182; W08661 111; W08661 113; W08661 124; W08661129/140; W086050150/152/154/185; W08661 139; W086050 147; W08661 110; W086050160/161/162; W086050 180; W086050 187.
Where was it sold?
Worldwide Distribution - USA including Oregon and California., and the countries of France, Belgium, Italy, Denmark, Norway, Switzerland, Romania, Finland, Germany, South Africa, Canada, Ireland, UK, Sweden and Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Copan Italia
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | of DTT in liquid phase, in PET tube with capture cap, in bulk recalled | Copan Italia | Other | 14 states |
| Device | CLASS II | of DTT in liquid phase, in PET tube with capture cap recalled | Copan Italia | Other | 14 states |
| Device | CLASS II | BD BBL CultureSwab EZ Collection and Transport System recalled | Copan Italia | Device Malfunction | Nationwide |
| Device | CLASS II | Copan FLOQSwabs, Sterile.EO, for drawing clinical samples recalled | Copan Italia | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |