Z-1188-2007

XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing...

Name: Z-1188-2007 XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing...
Creator: Abbott Diagnostic International, Ltd.
Published: 2007-05-31
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2007-05-31 / Terminated

FDA source

Abbott Diagnostic International, Ltd. began a recall of XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent... on 2007-05-31. The reason FDA records is "Controls Out of Range/Specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1188-2007
Status: Terminated
Initiated: 2007-05-31
Posted: 2007-08-22
Terminated: 2011-06-10
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
Product code: LGI Fluorescence Polarization Immunoassay, Carbamazepine
Reason for recall: Controls Out of Range/Specification.
FDA 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 in commerce: 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
Product codes and lots: 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

Product code LGI

K940682Class IIAxsym(tm) QuinidineAbbott Laboratories / cleared 1994-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)