FDA recall Z-0574-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-11-07

Report date

2019-12-04

Termination date

2023-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wiesbaden, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0574-2020