Recall Z-0987-2013
Abbott Laboratories, Inc · initiated December 18, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All shipped out to this date
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-determined 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.
Details
- Recall number
- Z-0987-2013
- Initiated
- December 18, 2012
- Posted by FDA
- March 25, 2013
- Terminated
- July 31, 2013
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Quantity
- 12
- Distribution
- Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
- Recalling firm
- Abbott Laboratories, Inc, Irving, TX