VIDAS Testosterone, Ref 30418
Reported: July 19, 2017 Initiated: May 15, 2017 #Z-2339-2017
Product Description
VIDAS Testosterone, Ref 30418
Reason for Recall
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
Details
- Recalling Firm
- bioMerieux, Inc.
- Units Affected
- 742
- Distribution
- AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
VIDAS Testosterone, Ref 30418. Recalled by bioMerieux, Inc.. Units affected: 742.
Why was this product recalled? ▼
Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2017. Severity: Moderate. Recall number: Z-2339-2017.
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