Z-1046-2009

AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme...

Name: Z-1046-2009 AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme...
Creator: Abbott Laboratories
Published: 2009-01-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-01-19 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative... on 2009-01-19. The reason FDA records is "Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1046-2009
Status: Terminated
Initiated: 2009-01-19
Posted: 2009-04-15
Terminated: 2010-09-11
Recalling firm: Abbott Medical
Product: AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20;
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Consignees were sent a Product Correction-Immediate Action Required letter on 1/19/09. The letter informed users of the reported increased frequency of probe crashes when using the affected reagent pack lots and provided instructions on what actions the laboratory can take if they have a defective reagent pack or experience a probe crash with their system. Users need 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 reagent pack on instrument; and discard any reagent packs that do not open properly. If a probe crash is observed prior to testing samples again, a probe crash recovery must be performed following the procedure in the Operations Manual. A copy of the communication needs to be provided to any laboratory that you may have forwarded affected lots to. Users were requested to return a customer reply letter acknowledging receipt and understanding of the letter. For additional information, contact Abbott Labs at 1-877-4ABBOTT.
Quantity in commerce: 1,540 kits
Distribution: Worldwide Distribution -- USA including Puerto Rico and countries of Germany, Mexico, Hong Kong, and Japan.
Product codes and lots: lot 66495M100

Product code LOM

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)