i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measureme

FDA device recall Z-2237-2012 · posted 2012-08-22 · Terminated

Recall details

Recalling firm

Abbott Point Of Care Inc.

Reason for recall

Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.

Action taken

Abbott Point of Care (APOC) sent an Urgent Recall Notice letters, via Fed Ex on March 07, 2012 to all affected customers. APOC sent an important product information update on July 19, 2012 to all of their affected customers. The letter identified the affected product, problem and actions to be taken. Customers are asked to review the information included as it may pertain to their cartridges. Customers were instructed that if the affected product have been forwarded to another facility, provide a copy of this letter to them. For additional information, contact APOC at 800-366-8020 option 1 or your Abbott Point of Care representative.

Root cause

Device Design

Status

Terminated

Product code

MMI

Quantity affected

7,057675 cartridges US; 772,400 cartridges OUS

Distribution

Worldwide Distribution - US Nationwide, International

Date initiated

2012-03-07

Date posted

2012-08-22

Date terminated

2013-02-19

Location

Princeton, NJ

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