Recall Z-1109-2017— Immuno-Mycologics, Inc

Name: FDA recall Z-1109-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-27

Class II · Terminated

Class II FDA medical device recall by Immuno-Mycologics, Inc, initiated 2016-12-27, terminated 2017-03-08. It names one FDA 510(k) clearance: K112422. Product: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003. Reason: 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..

Recalling firm: Immuno-Mycologics, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-12-27
Terminated: 2017-03-08
Firm location: Norman, OK, United States

510(k) clearances named in this recall

1 on FDA's record

K112422 — CRAG LATERAL FLOW ASSAY (LFA)Immuno-Mycologics, Inc.·cleared 2012-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.