Abbott Gmbh & Co. KG: Medical Device Recall in 2019 - (Recall #: Z-0574-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Product Classification:

Class II

Date Initiated: November 7, 2019

Date Posted: December 4, 2019

Recall Number: Z-0574-2020

Event ID: 84238

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.

Status: Terminated

Product Quantity: 83 kits

Code Information:

lot number 08219BE00

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

Voluntary or Mandated:

Voluntary: Firm initiated