Class 3 Device Recall WASP (Walk Away Specimen Process) Instrument software

• Date Initiated by Firm: August 09, 2013
• Date Posted: August 30, 2013
• Recall Status: Terminated on December 12, 2013
• Recall Number: Z-2131-2013
• Recall Event ID: 65923
• Product Classification: Device, microtiter diluting/dispensing - Product Code JTC
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Copan Italia; Via Perotti, 10; Brescia Italy
• Manufacturer 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.
• FDA Determined 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 involved in this upgrade are all whose serial numbers show the configuration with the broth inoculation feature activated. The machine installed in your laboratory is one of this serial number involved in the SW upgrade. The Software upgrade will be performed on site by personnel trained by Copan and no action is required by yourself. Customers will be contacted by the WASP Technical Support in order to define a date that will fit with their planning. Customers with questions are instructed to call +39 0303666130 or write to regulatory.wasp@copanitalia.com.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.