Company: Nidek Inc.
Date of Enforcement Report: 9/11/2013
Class llI:
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.
Recall Number Z-2131-2013
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/MANUFACTURER
Copan Italia SpA, Brescia, IT on 8/9/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide and Internationally
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