Drug recall
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium…
FDA recall event 62319 · Class II · Abbott Point Of Care Inc.
Key facts
| Event ID | 62319 |
|---|---|
| Recall numbers | Z-1973-2012, Z-1974-2012, Z-1975-2012, Z-1976-2012, Z-1977-2012, Z-1978-2012 |
| Recalling firm | Abbott Point Of Care Inc. |
| Product type | Devices |
| Products | 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…, i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540, i-STAT1 Abaxis Analyzer; 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…, iStat1 Analyzer 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 Portable Clinical Analyzer; 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… and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. |
| Initiation date | Sep 8, 2011 |
| Report date | Jul 18, 2012 |
| Termination date | Jan 28, 2013 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 2245578 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: