iStat1 Analyzer Abbott Point of Care recall
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2…
Why was iStat1 Analyzer Abbott Point of Care recalled?
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
510K K940918 Product Number/List Number 06F16-05; 06F16--10; 310000; 310001;; 310002 All lots
- Product
- iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2…
- Recalling firm
- Abbott Point Of Care Inc.
- Quantity
- 06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 units
- Distribution
- Worldwide Distribution - USA (nationwide)
- Recall date
- July 18, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)