[Recalled] Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are inte
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or cap |
|---|---|
| Brand / manufacturer | Abbott Point Of Care Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1975-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 08 September 2011 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.