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Terminated

AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064

FDA Recall Z-0627-03 · Posted 2003-03-06

Recalling FirmAbbott Health Products, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2002-12-13
Date Terminated2004-06-02
Product Quantity826 kits

Reason for Recall

Results lower than package insert ranges

Firm Action

Device Recall Letters were mailed to all Abbott customers World Wide on 12/11/02. The letter instructed to check their inventory for the recalled product, discontinue use and destroy it according to their laboratory procedures. If the product was forwarded to another laboratory, please provide them with a copy of the letter.

Root Cause

Other

Distribution Pattern

Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain

Official Source

View FDA Recall →

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

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