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Terminated

ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

FDA Recall Z-1728-2020 · Posted None

Recalling FirmAbbott Gmbh & Co. KG
Recall StatusTerminated
Product CodeLOL
Date Initiated2020-03-09
Date Terminated2021-02-11
Product Quantity7,347 kits

Reason for Recall

An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.

Firm Action

Abbott GmbH notified customers on 03/09/2020 via "Product Recall Urgent Immediate Action Required" letter. The recall letter identified the affected products and requested the customers to Immediately discontinue use of, and destroy, any remaining inventory of these ARCHITECT HAVABG reagent lots.

Root Cause

Mixed-up of materials/components

Distribution Pattern

US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.

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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