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Terminated

Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

FDA Recall Z-0451-2014 · Posted 2013-12-04

Recall StatusTerminated
Product CodeGJS
Date Initiated2013-10-28
Date Terminated2014-05-29
Product Quantity794,928 units US; 119,472 units OUS

Reason for Recall

Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.

Firm Action

Abbott Point of Care Inc. (APOC) issued an Urgent Recall Notice on October 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from PT/INR lots in this letter. All unused cartridges would be credited and are to be returned as instructed on the enclosed Business Reply Card. If customers provided cartridges from the lot number listed above to another institution they were instructed to provide a copy of this letter to them. Customers with questions were instructerd to contact Abbott Point of Care Technical at 1-800-366-8020, Option 1. For questions regarding this recall call 800-366-8020.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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