Recall Z-0574-2020 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Abbott Gmbh & Co. KG
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
| Date | Nov 26, 2019 (initiated Nov 7, 2019) |
| Status | Terminated |
| Reason | Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO. |
| Root cause | Material/Component Contamination |
| Action | The firm initiated the recall by letter on 11/07/2019. The letter explained the issue and requested that the consignee discontinue use of the product and destroy it. The firm is providing replacement material. |
| Quantity | 83 kits |
| Distribution | US in the states of: AZ, CA, CO, CT, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113704 | ARCHITECT HAVAB-G Abbott Laboratories, Jun 28, 2012 |