MicroVue SC5b-9 Plus EIA recall: Contamination
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in…
Why was MicroVue SC5b-9 Plus EIA recalled?
A component of the kit was found to contain bacterial contamination.
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?
Lot 052418
- Product
- MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in…
- Recalling firm
- Diagnostic Hybrids, Inc.
- Quantity
- 107 kits
- Distribution
- Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
- Recall date
- May 2, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)