FDA-Device2019-12-04Class II
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Abbott Gmbh & Co. KG
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.
Sold states
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
Affected count
83 kits
Manufactured in
Max-Planck-Ring 2, 65205, Wiesbaden, Germany
Products
ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0574-2020Don't want to check this manually?
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