CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report
Architect HBsAg Qualitative Assay, List Number 4P53 recalled
Abbott Laboratories is recalling Architect HBsAg Qualitative Assay, List Number 4P53 and Architect HBsAg Qualitative, distributed nationwide in the US. The recall was initiated on 18 Dec 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0987-2013
- FDA event ID
- 63946
- Recalling firm
- Abbott Laboratories, Irving, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2012
- FDA classified
- 25 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hepatitis A
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Dec 2012 | Recall initiated by company | |
| 25 Mar 2013 | Classified by FDA | +97 days |
| 3 Apr 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
Nationwide ArizonaCaliforniaFloridaGeorgiaHawaiiLouisianaMassachusettsMarylandMissouriNew JerseyNew YorkPennsylvaniaRhode IslandTennesseeTexasUtahWashington
Questions about this recall
Is Architect HBsAg Qualitative Assay, List Number 4P53 and Architect HBsAg Qualitative recalled?
Yes. Abbott Laboratories recalled Architect HBsAg Qualitative Assay, List Number 4P53 and Architect HBsAg Qualitative on 18 Dec 2012. The recall is Class II and its status is Terminated. Recall number Z-0987-2013.
Why was it recalled?
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
Which lots are affected?
All shipped out to this date
Where was it sold?
Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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