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
FDA Recall Z-1188-2007 · Posted 2007-08-22
Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeLGI
Date Initiated2007-05-31
Date Terminated2011-06-10
Product Quantity93
Reason for Recall
Controls Out of Range/Specification.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.