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i-STAT Analyzer recallZ-0593-2011 · Abbott Point Of Care Inc. · initiated Sep 20, 2010

Terminated All recalls posted in December 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Point Of Care Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0593-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 20, 2010
Posted by the FDA
Dec 10, 2010
Recalling firm
Abbott Point Of Care Inc.
Quantity
06F16-05: 45; 06F16-10: 22289; 310000: 4393; 310001: 1139; 310002: 11489.
Product code
CHL
FDA submissions
K940918
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.

Product description

i-STAT Analyzer; 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.

Code information (models, lots, serial numbers)

Product numbers: 06F16-05, 06F16-10, 310000, 310001, 310002; all lots

Other devices under the same FDA submission

5 devices cleared under K940918 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 56832).

Sources and updates

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