Cryptococcal Antigen Lateral Flow Assay recall
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Why was Cryptococcal Antigen Lateral Flow Assay recalled?
The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive 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?
161028133653JH, 161003111544KH, and 161007105036JG
- Product
- Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
- Recalling firm
- Immuno-Mycologics, Inc
- Quantity
- 630 units
- Distribution
- Nationwide throughout the US
- Recall date
- February 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)