PlainRecalls
FDA Devices Moderate Class II Terminated

ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Reported: December 4, 2019 Initiated: November 7, 2019 #Z-0574-2020

Product Description

ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Reason for Recall

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.

Details

Recalling Firm
Abbott Gmbh & Co. KG
Units Affected
83 kits
Distribution
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
Location
Wiesbaden

Frequently Asked Questions

What product was recalled? ▼
ARCHITECT HAVAB-G Calibrator, REF 6L27-01. Recalled by Abbott Gmbh & Co. KG. Units affected: 83 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0574-2020.

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