Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
This recall has been terminated (originally issued January 27, 2017).
- Company
- Immuno-Mycologics, Inc
- Recall Initiated
- December 27, 2016
- Posted
- January 27, 2017
- Terminated
- March 8, 2017
- Recall Number
- Z-1109-2017
- Quantity
- 630 units
- Firm Location
- Norman, OK
- Official Source
- View on FDA website ↗
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
Nationwide throughout the US
Lot / Code Info
161028133653JH, 161003111544KH, and 161007105036JG
Root Cause
Material/Component Contamination
Action Taken
Immuno sent an Urgent: Medical Device Recall Letter dated December 27, 2016, to all affected customers. All customers were notified via emails to stop using the product on December 27th and December 28th. A recall notification and response form was attached to the email. For further questions, please call (405)364-1058.
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