i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitativ

FDA device recall Z-2169-2012 · posted 2012-08-09 · Terminated

Recall details

Recalling firm

Abbott Point Of Care Inc.

Reason for recall

The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

Action taken

Abbott Point of Care (APOC) sent an URGENT RECALL NOTICE dated February 2012 to all affected customers via e-mail and also contacted by phone. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that if their facility was performing testing at more than approximately 7500 feet above sea level, they should have an alternate test method available should they experience an issue. If they have forwarded any cartridges to another facility, they should provide a copy of the Urgent Recall Notice to them. For questions customers were instructed to call 800-366-8020, Option 1 or contact their Abbott Point of Care representative. For questions regarding this recall call 609-454-9000.

Root cause

Device Design

Status

Terminated

Product code

MMI

Quantity affected

7,057,675 cartridges US ; 772,400 OUS

Distribution

Worldwide Distribution - USA including AZ and CO and internationally to Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Fi

Date initiated

2012-02-01

Date posted

2012-08-09

Date terminated

2013-02-08

Location

Princeton, NJ

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