medical Class II Updated 2019-12-04

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

Recalled Product

ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CO, CT, FL, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OR, RI, SC, TN, TX, WA, WV

Lot/Code Info: lot number 08219BE00

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