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Terminated

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

FDA Recall Z-1186-2007 · Posted 2007-08-22

Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeLGI
Date Initiated2007-05-31
Date Terminated2011-06-10
Product Quantity119

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.

K940682AXSYM(TM) QUINIDINEAbbott Laboratories · 1994-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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