Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada.
FDA Recall Z-0374-2008 · Posted 2007-12-11
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Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeJGS
Date Initiated2007-10-18
Date Terminated2008-07-18
Reason for Recall
Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
Firm Action
Abbott Point of Care sent and Urgent Notice to all i-STAT Customers (US and Canadian consignees) notifying them that certain lots of i-STAT cartridges have snap closures that are difficult to close, will not close or do not stay closed. The customers were asked to review the lot numbers on the enclosure and, if the facility has any cartridges from the lot numbers listed, they should remove from service immediately.
Root Cause
Packaging change control
Distribution Pattern
Worldwide Distribution- including USA and country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K001154I-STAT MODEL 200 PORTABLE CLINICAL ANALYZERI-Stat Corp. · 2000-04-18K936081I-STAT TESTS FOR ACID-BASE PARAMETERSI-Stat Corp. · 1994-02-24K912387I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACKI-Stat Corp. · 1991-07-01K894914MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACKI-Stat Corp. · 1989-10-16
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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