Optilite Igm Kit recall
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Why was Optilite Igm Kit recalled?
There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
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 # 422251
- Product
- OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 3294 kits
- Distribution
- CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,
- Recall date
- February 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)