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Terminated

i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test.

FDA Recall Z-0912-05 · Posted 2005-06-21

Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeJBP
Date Initiated2005-03-16
Date Terminated2006-06-30
Product Quantity298006 cartridges

Reason for Recall

Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.

Firm Action

The firm provided an 'Urgent Letter', acknowledgement form, floppy disks, and labels to all customers who received the celite ACT cartridge.

Root Cause

Other

Distribution Pattern

The cartridges have been distributed to hospitals and clinics nationwide. The cartridges have been distributed to Austria, Australia, Canada, Switzerland, China, Colombia, Germany, France, Greece, Hong Kong, India, New Zealand, and Singapore. There are 15 VA hospitals identified. There are 3 government and military accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992571I-STAT SYSTEMI-Stat Corp. · 2000-02-10

Official Source

View FDA Recall →

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

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