Abbott Gmbh & Co. KG recalls ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Recall date

November 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0574-2020

FDA classification

Class II

Brand / firm

Abbott Gmbh & Co. KG

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARCHITECT HAVAB-G Calibrator, REF 6L27-01