The Recall Desk
ModerateFDA (Devices)·Z-0987-2013·Announced 2013-04-03

Abbott Recalls ARCHITECT HBsAg Assay Files Due to Unauthorized Website Availability

Abbott is recalling ARCHITECT HBsAg assay files because they were mistakenly made available on its website and via AbbottLink notifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard involves unauthorized availability of software files rather than a direct physical defect or reported illness, fitting the criteria for minor labeling or documentation issues.

Plain-English summary

Abbott Laboratories, Inc. is recalling the ARCHITECT HBsAg Qualitative Assay (List Number 4P53) and the ARCHITECT HBsAg Qualitative Confirmatory Assay (List Number 4P54). These are chemiluminescent microparticle immunoassays used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma, as well as neonate serum.

The recall was initiated because Abbott identified that the assay files for these specific list numbers 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 these assay files were available.

The affected products were distributed nationwide, including to Arizona, California, Florida, Georgia, Hawaii, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, and Washington. The source text does not specify the total number of units affected or provide specific instructions for consumers on how to dispose of or return the files.

The recalled product

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 (H
Manufacturer
Abbott Laboratories, Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All shipped out to this date

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Related recalls

Same manufacturer · Abbott Laboratories, Inc

See all →