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STATSENSOR
NOVA BIOMEDICAL CORPORATION · Model 1.0 · UDI-DI 10385480433706
CGL
Prescription
1
510(k) clearances
196
Adverse events (3 deaths)
9
Recalls
11
Facilities
Description
STAT SENSOR CREAT - Test Strips
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2014-10-29 | Radiometer America Inc | Negative drift on QC during in-use lifetime of CREA membranes can be observed. |
| 2011-12-16 | Radiometer America Inc | When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to l |
| 2010-03-17 | Abbott Point of Care Inc. | The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks. |
| 2009-03-26 | Radiometer America Inc | Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. Th |
| 2008-08-11 | Nova Biomedical Corporation | Erroneous, low creatinine results on CCX analyzer |
| 2007-11-02 | Nova Biomedical Corporation | Incorrect Results - Creatinine results were lower than the laboratory reference method. |
| 2007-11-02 | Nova Biomedical Corporation | Incorrect Results - Creatinine results were lower than the laboratory reference method. |
| 2007-11-02 | Nova Biomedical Corporation | Incorrect Results - Creatinine results were lower than the laboratory reference method. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.