Z-1186-2007

AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low...

Name: Z-1186-2007 AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low...
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 AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing quinidine... 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-1186-2007
Status: Terminated
Initiated: 2007-05-31
Posted: 2007-08-22
Terminated: 2011-06-10
Recalling firm: Abbott Diagnostic International, Ltd.
Product: AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing quinidine prepared in human serum to yield the different concentration ranges-Product List Number 7A73-10
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: 119
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 # 43273Q100 Exp. Date: 06/23/2007 and Lot # 47028Q100 Exp. Date; 10/14/2007

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)