Recalling Firm / Manufacturer

Abbott Laboratories MPG

Product

AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

Code Information

list 04B47;48069M200

Reason of Recall

Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

Date Recall Initiated

April 23, 2007

Action

Abbott initiated a field correction recall by letter dated 4/23/07 to all customers receiving the affected reagents. The accounts were informed of the failure of the AxSYM to open (actuate) some reagent packs with the affected lots. The accounts were requested to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading the reagent pack on the instrument; and discard any reagent packs that do not open properly. If the user observes a probe crash, prior to testing samples again, the user must perform a probe crash recovery following the procedure in the Operations Manual. If necessary, they need to replace the probe. If a probe crash recovery is not performed, subsequent results may be impacted. The customers were requested to retain a copy of the letter for their records. Customers requiring additional information were directed to contact Abbott Customer Service .Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.