Nova - EZ CHEM Linearity Solution P/N 9618, 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-0726-2008
- Quantity
- 286 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: 4307236990 and 4307270990
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.
More recalls by Nova Biomedical Corporation
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose...
Dec 20, 2024
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood...
Dec 20, 2024
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription u...
Dec 20, 2024