Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454
- Company
- Nova Biomedical Corporation
- Recall Initiated
- November 2, 2007
- Posted
- February 16, 2008
- Terminated
- December 9, 2008
- Recall Number
- Z-0725-2008
- Quantity
- 300 units
- Firm Location
- Waltham, MA
Reason for Recall
Incorrect Results - Creatinine results were lower than the laboratory reference method.
Distribution
Nationwide Distribution, including the state of NY
Lot / Code Info
Lot Numbers: 4207225241 and 4207261241
Root Cause
Device Design
Action Taken
Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at gvogelsberg@ezem.com.
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