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Terminated

i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

FDA Recall Z-1976-2012 · Posted 2012-07-09

Recall StatusTerminated
Product CodeCHL
Date Initiated2011-09-08
Date Terminated2013-01-28
Product Quantity6000-0000-650 units

Reason for Recall

Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

Firm Action

Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose of all Old Battery Carriers per local regulations. If customers forward the affected product to another facility, they should provide a copy of the recall letter to them and advise them to replace the carriers if required. For any questions call 800-366-8020, Option 1 or your Abbott Point of Care representative. For questions regarding this recall call 609-454-9272.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA (nationwide)

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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