FDA Medical Device Recalls (openFDA)
Nova Biomedical Corporation: Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454
- Recall number
- Z-0725-2008
- Recalling firm
- Nova Biomedical Corporation
- Product
- Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454
- Status
- Terminated
- Initiated
- 2007-11-02
- Posted
- 2008-02-16
- Terminated
- 2008-12-09
- Reason
- Incorrect Results - Creatinine results were lower than the laboratory reference method.
- Root cause
- Device Design
- 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 gvogelsberg@ezem.com.
- Quantity
- 300 units
- Distribution
- Nationwide Distribution, including the state of NY
- Lot, serial or model codes
- Lot Numbers: 4207225241 and 4207261241
- 510(k) numbers
- ["K070068"]
- PMA numbers
- not on file
- Product code
- CGL
- Firm FEI
- 1219029
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28