Z-0987-2013Class II

ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List...

Name: Z-0987-2013 ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List...
Creator: Abbott Laboratories, Inc
Published: 2012-12-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-12-18 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay... on 2012-12-18. FDA classified it as Class II and gives the reason as "Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0987-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-18
Posted: 2013-03-25
Terminated: 2013-07-31
Recalling firm: Abbott Medical
Product: ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR
FDA root cause: No Marketing Application
Action: The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.
Quantity in commerce: 12
Distribution: Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
Product codes and lots: All shipped out to this date

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0987-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0987-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-25

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)