ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54
FDA device recall Z-0987-2013 · posted 2013-03-25 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- 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
- Action taken
- The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- LOM
- Quantity affected
- 12
- Distribution
- Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
- Date initiated
- 2012-12-18
- Date posted
- 2013-03-25
- Date terminated
- 2013-07-31
- Location
- Irving, TX
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