Recall Z-1973-2012— Abbott Point Of Care Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2011-09-08, terminated 2013-01-28. It names one FDA 510(k) clearance: K001387. Product: 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 System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels.. Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension..
- Recalling firm
- Abbott Point Of Care Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-09-08
- Terminated
- 2013-01-28
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels.
Reason for recall
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Data sourced from openFDA. This site is unofficial and independent of the FDA.