Recall Z-0467-2015— Biomerica

Name: FDA recall Z-0467-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-18

Class II · Terminated

Class II FDA medical device recall by Biomerica, initiated 2014-09-18, terminated 2015-03-28. It names one FDA 510(k) clearance: K982491. Product: Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.. Reason: A potential issue with false high values..

Recalling firm: Biomerica
Classification: Class II
Status: Terminated
Initiated: 2014-09-18
Terminated: 2015-03-28
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K982491 — SANGUI BIOTECH, INC. CALCITONIN ELISA KITSangui Biotech, Inc.·cleared 1998-09-03

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

Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.

Reason for recall

A potential issue with false high values.

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