Z-0417-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- October 16, 2014
- Termination Date
- September 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171
Product Description
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Reason for Recall
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Distribution Pattern
Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.
Code Information
Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)