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Terminated

ARCHITECT HAVAB-G Calibrator, REF 6L27-01

FDA Recall Z-0574-2020 · Posted 2019-11-26

Recalling FirmAbbott Gmbh & Co. KG
Recall StatusTerminated
Product CodeLOL
Date Initiated2019-11-07
Date Terminated2023-08-31
Product Quantity83 kits

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.

Firm Action

The firm initiated the recall by letter on 11/07/2019. The letter explained the issue and requested that the consignee discontinue use of the product and destroy it. The firm is providing replacement material.

Root Cause

Material/Component Contamination

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113704ARCHITECT HAVAB-GAbbott Laboratories · 2012-06-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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