FDA Medical Device Recalls (openFDA)
Abbott Diagnostic International, Ltd.: Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
- Recall number
- Z-0117-2007
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Product
- Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
- Status
- Terminated
- Initiated
- 2006-09-08
- Posted
- 2006-11-17
- Terminated
- 2012-01-24
- Reason
- Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
- Root cause
- Other
- Action
- not on file
- Quantity
- 2,355 boxes of 100
- Distribution
- Nationwide including the states of AL, AK, AZ, CA, CT, CO, DE, FL, GA, ID, IL, IA, IN, KS, KY, LA, MA, ME, MI, MS, MN, MT, MO, NM, NJ, NY, NV, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, Hawaii and Puerto Rico
- Lot, serial or model codes
- Lot # 37618Q100 Expiration Date 12/05/2006
- 510(k) numbers
- ["K041811","K974651"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2623532
- Firm city
- Barceloneta
- Firm state
- PR
- Firm country
- not on file
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