Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454
FDA Recall Z-0725-2008 · Posted 2008-02-16
Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeCGL
Date Initiated2007-11-02
Date Terminated2008-12-09
Product Quantity300 units
Reason for Recall
Incorrect Results - Creatinine results were lower than the laboratory reference method.
Firm Action
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 [email protected].
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution, including the state of NY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.