ARCHITECT HAVAB-G Calibrator, REF 6L27-01
- Recall Initiated
- November 7, 2019
- Posted
- November 26, 2019
- Terminated
- August 31, 2023
- Recall Number
- Z-0574-2020
- Quantity
- 83 kits
Reason for Recall
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.
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
Lot / Code Info
lot number 08219BE00
Root Cause
Material/Component Contamination
Action Taken
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.