Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
Lot Codes / Batch Numbers
Lot # 43273Q100 Exp. Date: 06/23/2007 and Lot # 47028Q100 Exp. Date, 10/14/2007
Products Sold
Lot # 43273Q100 Exp. Date: 06/23/2007 and Lot # 47028Q100 Exp. Date; 10/14/2007
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila is recalling AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control due to Controls Out of Range/Specification .. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Controls Out of Range/Specification .
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CT, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WA, WV, WI, PR
Page updated: Jan 10, 2026