Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 recallZ-0724-2008 · 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-0724-2008
- 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
- 133 units
- Product code
- CGL
- FDA submissions
- K070068
- Distribution
- Nationwide Distribution, including the state of NY
Product description
Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Serial Numbers: 39000207226 39000207229 39000207256 39000207270 39000307226 39000307229 39000307256 39000307270 39000407229 39000407270 39000507226 39000507229 39000507270 39000607229 39000607270 39000707229 39000707270 39000807226 39000807229 39000907270 39001007229 39001007256 39001007270 39001107229 39001107256 39001107270 39001207256 39001207270 39001307256 39001307270 39001407256 39001407270 39001507256 39001507270 39001607256 39001607270 39001707256 39001707270 39001807256 39001807270 39001907256 39001907270 39002007256 39002007270 39002107256 39002107270 39002207256 39002207270 39002307256 39002307270 39002407256 39002407270 39002507256 39002507270 39002607256 39002707256 39002907256 39003007256 39003107256 39003207256 39003307256 39006207249 39006307249 39006407249 39006507249 39006607249 39006607263 39006707249 39006707263 39006807249 39006807263 39006907249 39006907263 39007007263 39007107263 39007207263 39007307249 39007407249 39007507249 39007807249 39007907249 39008007249 39008107249 39008207249 39008307249 39008407249 39008507249 39008607249 39009607263 39009707263 39009807263 39009907263 39010007263 39010507275 39010607275 39010707275 39010807275 39010907275 39011007275 39011107275 39011207275 39011507275 39011607275 39011707275 39011807275 39011907275 39012007275 39012107275 39012307275 39012807275 39012907275 39013007275 39013207275 39013307275 39013407275 39013507275 39013607275 39013707275 39013807275 39013907275 39014107275 39014207275 39014307275 39014407275 39014507275 39014607275 39014707275 39014807275 39014907275 39015007275 39015107275 39015207275 39015307275
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-0725-2008 · TerminatedNova - EZ CHEM Control Solution P/N 9612, 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.
How recalls are matched to devices · Editorial policy · Report an error on this page