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Terminated

Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct); List No: 06F08-01; Part No: 120500; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.

FDA Recall Z-0371-2008 · Posted 2007-12-11

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.

K912387I-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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