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Terminated

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003

FDA Recall Z-1109-2017 · Posted 2017-01-27

Recalling FirmImmuno-Mycologics, Inc
Recall StatusTerminated
Product CodeGMD
Date Initiated2016-12-27
Date Terminated2017-03-08
Product Quantity630 units

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.

Firm Action

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.

Root Cause

Material/Component Contamination

Distribution Pattern

Nationwide throughout the US

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112422CRAG LATERAL FLOW ASSAY (LFA)Immuno-Mycologics, Inc. · 2012-03-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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