FDA Medical Device Recalls (openFDA)
Abbott Health Products, Inc.: AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064
- Recall number
- Z-0627-03
- Recalling firm
- Abbott Health Products, Inc.
- Product
- AFP Control Kit distributed under the following label: AxSYM and IMx, Abbott Laboratories USA, North Chicago, IL 60064
- Status
- Terminated
- Initiated
- 2002-12-13
- Posted
- 2003-03-06
- Terminated
- 2004-06-02
- Reason
- Results lower than package insert ranges
- Root cause
- Other
- 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.
- Quantity
- 826 kits
- Distribution
- Distribution nationwide and Japan, Singapore, Australia, New Zealand, and Great Britain
- Lot, serial or model codes
- Product list number: 9C05-10 Lot No.: 91533Q100 Exp. date: 10/20/2003
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2623532
- Firm city
- Barceloneta
- Firm state
- not on file
- Firm country
- PR
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28