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 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 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

Recall Insight

This FDA Devices action (record #Z-1974-2012) was formally reported on July 18, 2012, with the manufacturer initiating the action on September 8, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Point Of Care Inc. is listed as the recalling firm, operating out of Princeton, NJ. Federal records indicate 06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 210002-5359 UNITS; 210003-9051 UNITS units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide). Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.