i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.
FDA Recall Z-0812-2010 · Posted 2010-02-24
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Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2009-09-09
Date Terminated2014-12-08
Product Quantity3,918 analyzers
Reason for Recall
The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
Firm Action
An "Urgent Recall Notice" was issued to customers during September 2009. The letter described the affected product, issue and recommended actions. Customers were asked to verify storage conditions on the box are correct and if not, discard the outside box. If the customer requires a replacement box, the customer must contact Abbott Point of Care Technical Support. Direct questions and requests for additional information to the Abbott Point of Care Technical Support by calling 1-800-366-8020, Option 1 or contact your Abbott Point of Care representative.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution (including the United States).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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