Reported Apr 29, 2020 · Terminated

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

Abbott GmbH & Co. KG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Gmbh & Co. KG · Max-Planck-Ring 2 · Wiesbaden, N/A · N/A

Is this the product you have?

  • ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Lot codes and dates
  • List Number 6L27 25
  • Lot No
    • 03429BE00
    • 06172BE00
    • 08073BE00
    • 10353BE00
  • UDI
    • (01)00380740011185 (17)200320(10)03429BE00
    • (01)00380740011185 (17)200604(10)06172BE00
    • (01)00380740011185 (17)200819(10)08073BE00
    • (01)00380740011185 (17)201023(10)10353BE00
Amount recalled
7,347 kits

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 11, 2021 · Data as of Sep 19, 6:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.