Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended

FDA device recall Z-1328-2009 · posted 2009-05-07 · Terminated

Recall details

Recalling firm

Nova Biomedical Corporation

Reason for recall

Erroneous, low creatinine results on CCX analyzer

Action taken

Initial: USA and Canada - Customer Advisory Notice notification by phone contact with key customer contact facilitated using a Field Correction Script. This contact will be documented within the Nova Biomedical Technical Support database (Pivotal) and on a Field Correction Checklist. All affected inventory will be replaced at customer sites. International - Customer Advisory Notice and Faxback Form being communicated and sent to Nova Biomedical Subsidiaries and Distributors by three methods of delivery (Email, Fax and Phone Call). Follow-up: USA and Canada - Sending the Customer Advisory Notice by email and/or fax to the key customer contact from the initial phone contact. International - Sending the Customer Advisory Notice by email and/or fax to the key contact.

Root cause

Process control

Status

Terminated

Product code

CGL

Quantity affected

1230

Distribution

Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong.

Date initiated

2008-08-11

Date posted

2009-05-07

Date terminated

2011-07-22

Location

Waltham, MA

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