AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064
FDA device recall Z-0627-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Results lower than package insert ranges
- Action taken
- 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
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 826 kits
- Distribution
- Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain
- Date initiated
- 2002-12-13
- Date posted
- 2003-03-06
- Date terminated
- 2004-06-02
- Location
- Barceloneta, PR
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