Recall Z-2131-2013 ยท JTC Device, Microtiter Diluting/Dispensing
Copan Italia
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.
| Date | Aug 30, 2013 (initiated Aug 9, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Copan sent an Urgent WASP recall letter dated July 31, 2013, to all affected customers that received the WASP (Walk Away Specimen Process) instrument to notify them of the software upgrade 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. This event may happen only if damage in the door locking system happens. This could result in a minor, transient injury to the user due to the impact with the rotating table. The WASP instruments involv |
| Quantity | 63 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.