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Recall Observatory FDA recall evidence

Device product

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

Z-1728-2020

March 09, 2020

Class II

Product summary

Firm
Abbott Gmbh & Co. KG
Event
Event 85238
Status
Terminated
Classification
Class II
Quantity
7,347 kits
Official record key
device-enforcement:Z-1728-2020

Official wording

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

Code information: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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