Recall Z-1689-2016— Diamedix Corporation
Class II · Terminated
Class II FDA medical device recall by Diamedix Corporation, initiated 2015-03-26, terminated 2018-11-14. It names one FDA 510(k) clearance: K981163. Product: Diamedix Is-CMV IgG Test Kit. Reason: Product contained an incorrect substrate..
- Recalling firm
- Diamedix Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-26
- Terminated
- 2018-11-14
- Firm location
- Miami Lakes, 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
Diamedix Is-CMV IgG Test Kit
Reason for recall
Product contained an incorrect substrate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.