Recall Z-0987-2013 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Abbott Laboratories, Inc
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.
| Date | Mar 25, 2013 (initiated Dec 18, 2012) |
| Status | Terminated |
| Reason | 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 |
| 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 | 12 |
| Distribution | Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.