Z-1109-2017 Class II Terminated
FDA device recall Z-1109-2017 was initiated by Immuno-Mycologics, Inc on December 27, 2016 and is designated Class II. 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 … The recall status is terminated (terminated March 8, 2017). Affected quantity: 630 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2017
- Initiation Date
- December 27, 2016
- Termination Date
- March 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 630 units
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.
Distribution Pattern
Nationwide throughout the US
Code Information
161028133653JH, 161003111544KH, and 161007105036JG