Recall Z-0676-2019— Tosoh Bioscience Inc

Name: FDA recall Z-0676-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-30

Class II · Terminated

Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-11-30, terminated 2021-01-14. It names one FDA 510(k) clearance: K111335. Product: ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome..

Recalling firm: Tosoh Bioscience Inc
Classification: Class II
Status: Terminated
Initiated: 2018-11-30
Terminated: 2021-01-14
Firm location: Grove City, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K111335 — ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321Tosoh Bioscience, Inc.·cleared 2011-12-01

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

ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adrenocorticotropic hormone (ACTH) in human EDT A plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency and the ectopic ACTH syndrome.

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