Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical… recallZ-0725-2008 · Nova Biomedical Corporation · initiated Nov 2, 2007
Terminated All recalls posted in February 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nova Biomedical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect Results - Creatinine results were lower than the laboratory reference method.
FDA root cause category: Device Design
What the company is doing
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].
Recall details
- Recall number
- Z-0725-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 2, 2007
- Posted by the FDA
- Feb 16, 2008
- Recalling firm
- Nova Biomedical Corporation
- Quantity
- 300 units
- Product code
- CGL
- FDA submissions
- K070068
- Distribution
- Nationwide Distribution, including the state of NY
Product description
Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454
Code information (models, lots, serial numbers)
Lot Numbers: 4207225241 and 4207261241
Other devices under the same FDA submission
3 devices cleared under K070068 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STATSENSOR 1.0Nova Biomedical Corporation · ELECTRODE, ION BASED, ENZYMATIC, CREATININE5 reports
- StatSensor 1.0Nova Biomedical Corporation · ELECTRODE, ION BASED, ENZYMATIC, CREATININE3 reports
- StatSensor 1.0Nova Biomedical Corporation · ELECTRODE, ION BASED, ENZYMATIC, CREATININE2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 45815).
- Z-0724-2008 · TerminatedNova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454
- Z-0726-2008 · TerminatedNova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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