—#52077

Product

AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

FDA product code: LOL — Hepatitis A Test (Antibody And Igm Antibody)
Device class: Class 2
Medical specialty: Microbiology
PMA numbers: P790019
Affected lot / code info: list 05E20; lot 48466M100, 50410M200

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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 at 1-877-422-2688.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela.

Timeline

Recall initiated: 2007-04-23
Posted by FDA: 2007-07-11
Terminated: 2008-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52077. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.