Recall Z-1728-2020 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Abbott Gmbh & Co. KG
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
| Date | Mar 9, 2020 |
| Status | Terminated |
| Reason | An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots. |
| Root cause | Mixed-up of materials/components |
| Action | Abbott GmbH notified customers on 03/09/2020 via "Product Recall Urgent Immediate Action Required" letter. The recall letter identified the affected products and requested the customers to Immediately discontinue use of, and destroy, any remaining inventory of these ARCHITECT HAVABG reagent lots. |
| Quantity | 7,347 kits |
| Distribution | US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113704 | ARCHITECT HAVAB-G Abbott Laboratories, Jun 28, 2012 |