FDA Medical Device Recalls (openFDA)
Abbott Diagnostic International, Ltd.: XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number 9506-10
- Recall number
- Z-1188-2007
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Product
- XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number 9506-10
- Status
- Terminated
- Initiated
- 2007-05-31
- Posted
- 2007-08-22
- Terminated
- 2011-06-10
- Reason
- Controls Out of Range/Specification.
- Root cause
- Other
- Action
- May 31, 2007, Product Correction Letter to Customers were instructed to: "Revise the expiration date for all lots identified in the customer letter. "Discontinue use of the expired lots, and discard the material according to their laboratory procedures. "An additional option is to use the Abbott Immunoassay Multiconstituent Control (List Number 06E20), manufactured by BIO-RAD.
- Quantity
- 93
- Distribution
- Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
- Lot, serial or model codes
- Lot # 44161Q100 Exp. Date: 08/23/2007, Lot # 46295Q100 Exp. Date: 8/23/2007, Lot # 48239Q100 Exp. Date: 01/04/2008, and Lot# 50238Q100 Exp. Date: 05/20/2008
- 510(k) numbers
- ["K940682"]
- PMA numbers
- not on file
- Product code
- LGI
- 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