IMO-402 Mononucleosis Rapid Test Device recall
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic…
Why was IMO-402 Mononucleosis Rapid Test Device recalled?
Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in the rapid test may produce false negative results.
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?
The affected control lot number is 11030386. Lot/Unit Codes: MON1040008 & MON1040016.
- Product
- IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic…
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- 78 kits
- Distribution
- Nationwide Distribution including TN, WA, UT, KS, KY, MN, GA, MA, PA, NY, VT, and the Dist. of Columbia
- Recall date
- April 24, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)