Recall Z-0445-2013— Diamedix Corporation
Class II · Terminated
Class II FDA medical device recall by Diamedix Corporation, initiated 2012-08-06, terminated 2014-08-08. It names one FDA 510(k) clearance: K970220. Product: The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.. Reason: Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification..
- Recalling firm
- Diamedix Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-06
- Terminated
- 2014-08-08
- Firm location
- Miami, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
Reason for recall
Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.