Recall Z-2613-2017— Abbott Laboratories

Name: FDA recall Z-2613-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-18

Class II · Terminated

Class II FDA medical device recall by Abbott Laboratories, initiated 2017-04-18, terminated 2019-06-03. It names one FDA 510(k) clearance: K060818. Product: ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.. Reason: Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Terminated
Initiated: 2017-04-18
Terminated: 2019-06-03
Firm location: Abbott Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K060818 — ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01Biokit, S.A.·cleared 2007-01-23

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 SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.

Reason for recall

Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.

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