Z-1039-2007

AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott...

Name: Z-1039-2007 AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott...
Creator: Abbott Laboratories
Published: 2007-04-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-04-23 / Terminated

FDA source

Abbott Laboratories began a recall of AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064 on 2007-04-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1039-2007
Status: Terminated
Initiated: 2007-04-23
Posted: 2007-07-11
Terminated: 2008-05-18
Recalling firm: Abbott Medical
Product: AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
Reason for 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.
FDA root cause: Other
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 at 1-877-422-2688.
Quantity in commerce: 1,111 packs
Distribution: 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.
Product codes and lots: list 08D21-20; lots 48132M200, 48139M200, 51069M100

Product code LOL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)