FDANovember 7, 2019device

ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

abbott gmbh co kgabbottabbott gmbh

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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