Recall Z-1728-2020— Abbott Gmbh & Co. KG

Name: FDA recall Z-1728-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-09

Class II · Terminated

Class II FDA medical device recall by Abbott Gmbh & Co. KG, initiated 2020-03-09, terminated 2021-02-11. It names one FDA 510(k) clearance: K113704. Product: ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.. 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..

Recalling firm: Abbott Gmbh & Co. KG
Classification: Class II
Status: Terminated
Initiated: 2020-03-09
Terminated: 2021-02-11
Firm location: Wiesbaden, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K113704 — ARCHITECT HAVAB-GAbbott Laboratories·cleared 2012-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.