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.
This recall has been terminated (originally issued March 25, 2013).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- December 18, 2012
- Posted
- March 25, 2013
- Terminated
- July 31, 2013
- Recall Number
- Z-0987-2013
- Quantity
- 12
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
Lot / Code Info
All shipped out to this date
Root Cause
No Marketing Application
Action Taken
The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.