Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.
FDA Recall Z-2328-2009 · Posted 2009-09-30
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Recalling FirmAbbott Point of Care Inc.
Recall StatusTerminated
Product CodeCGA
Date Initiated2009-04-22
Date Terminated2010-02-25
Product Quantity2552
Reason for Recall
It appears that the rechargeable battery pack is overheating with or without the presence of smoke.
Firm Action
Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution
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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