Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Reported: February 8, 2017 Initiated: December 27, 2016 #Z-1109-2017
Product Description
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Reason for Recall
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.
Details
- Recalling Firm
- Immuno-Mycologics, Inc
- Units Affected
- 630 units
- Distribution
- Nationwide throughout the US
- Location
- Norman, OK
Frequently Asked Questions
What product was recalled? ▼
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003. Recalled by Immuno-Mycologics, Inc. Units affected: 630 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2017. Severity: Moderate. Recall number: Z-1109-2017.
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