Recall Z-2131-2013— Copan Italia
Class III · Terminated
Class III FDA medical device recall by Copan Italia, initiated 2013-08-09, terminated 2013-12-12. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..
- Recalling firm
- Copan Italia
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-08-09
- Terminated
- 2013-12-12
- Firm location
- Brescia, N/A, Italy
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.