ARCHITECT HAVAB-G Calibrator, REF 6L27-01
Published December 4, 2019 · Recall initiated: November 7, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Gmbh & Co. KG
- Distributor
- 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
- Lot
- lot number 08219BE00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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