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Terminated

i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540

FDA Recall Z-0318-2011 · Posted 2010-11-03

Recalling FirmAbbott Point Of Care Inc.
Recall StatusTerminated
Product CodeCHL
Date Initiated2008-01-01
Date Terminated2011-09-14
Product Quantity482,500 (total)

Reason for Recall

i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.

Firm Action

Abbott Point Of Care Inc.sent notification letters with a customer reply form to all affected customer in January, 2008. All distributors outside the US who were sent shipments from the affected lots were notified of the lot numbers that were affected. Affected product is to be quarantined and returned for replacement. Customers with questions about this recall can contact Abbott Point Of Care at 609 454-9000.

Root Cause

Other

Distribution Pattern

Worldwide Distribution: USA and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051433I-STAT CREATINE KINASE MB (CK-MB)I-Stat Corporation · 2005-12-15

Official Source

View FDA Recall →

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

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