Recall Z-1186-2007 ยท LGI Fluorescence Polarization Immunoassay, Carbamazepine
Abbott Diagnostic International, Ltd.
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
| Date | Aug 22, 2007 (initiated May 31, 2007) |
| Status | Terminated |
| Reason | Controls Out of Range/Specification . |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940682 | AXSYM(TM) QUINIDINE Abbott Laboratories, Jun 21, 1994 |