Nova Biomedical Corporation Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454
Brand
Nova Biomedical Corporation
Lot Codes / Batch Numbers
Lot Numbers: 4307236990 and 4307270990
Products Sold
Lot Numbers: 4307236990 and 4307270990
Nova Biomedical Corporation is recalling Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 due to Incorrect Results - Creatinine results were lower than the laboratory reference method.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Results - Creatinine results were lower than the laboratory reference method.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026