FDA Medical Device Recalls (openFDA)
Abbott Point Of Care Inc.: Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
- Recall number
- Z-0596-2011
- Recalling firm
- Abbott Point Of Care Inc.
- Product
- Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2 and the i-stat portable analyzer as part of the i-STAT system, are intended for use in the in vitro quantization of arterial, venous or capillary whole blood.
- Status
- Terminated
- Initiated
- 2010-09-20
- Posted
- 2010-12-10
- Terminated
- 2013-01-28
- Reason
- i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
- Root cause
- Other
- Action
- Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed. Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action. Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011.
- Quantity
- 04J48-20 - 1069; 215001 - 217.
- Distribution
- Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Finland, Georgian Republic, Greece, Honduras, France, Germany, Italy, Netherlands, New Zealand, Hong Kong, India, Ireland, Israel, Japan, Kingdom of Saudi Arabia, Korea, Kuwait, Mauritius, Mexico, Nigeria, Norway, Panama, Paraguay, Peoples Republic of China, Peru, Poland, Portugal, Qatar, Russia, Singapore, South Africa, Spain, Sweden, UK, Sultanate of Oman, Switzerland, Taiwan, R.O.C., Thailand, Turkey, UAE, Uruguay, and Yemen.
- Lot, serial or model codes
- Product numbers: 04J48-20, 215001; all lots
- 510(k) numbers
- ["K940918"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 2245578
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28