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
This recall has been terminated (originally issued August 22, 2007).
- Recall Initiated
- May 31, 2007
- Posted
- August 22, 2007
- Terminated
- June 10, 2011
- Recall Number
- Z-1188-2007
- Quantity
- 93
- Firm Location
- Barceloneta, PR
- Official Source
- View on FDA website ↗
Reason for Recall
Controls Out of Range/Specification.
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 / Code Info
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
Root Cause
Other
Action Taken
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.