Recall Z-2573-2018— Diamedix Corporation

Name: FDA recall Z-2573-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-05

Class III · Terminated

Class III FDA medical device recall by Diamedix Corporation, initiated 2018-01-05, terminated 2019-11-05. It names one FDA 510(k) clearance: K991274. Product: Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540. Reason: Contains a gel-like contaminant that may affect product performance..

Recalling firm: Diamedix Corporation
Classification: Class III
Status: Terminated
Initiated: 2018-01-05
Terminated: 2019-11-05
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K991274 — MUMPS IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.·cleared 1999-09-03

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

Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

Reason for recall

Contains a gel-like contaminant that may affect product performance.

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