Z-0574-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- November 7, 2019
- Termination Date
- August 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 kits
Product Description
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
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 Pattern
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
Code Information
lot number 08219BE00