MicroVue Bb Plus EIA is recall
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Why was MicroVue Bb Plus EIA is recalled?
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)
- Product
- MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
- Recalling firm
- Diagnostic Hybrids Inc
- Quantity
- 171
- Distribution
- 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.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)