Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 18, 2018
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Immuno-Mycologics, Inc recalled Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The … - a moderate-severity action.
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The … was recalled by Immuno-Mycologics, Inc in July 18, 2018. Reason: Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results. Check the official notice for the remedy. Verify recall #Z-2409-2018 with the FDA Devices before acting.
The recall
Immuno-Mycologics, Inc issued this moderate-severity FDA Devices recall-Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results.
- Moderate
- severity level
- 875 units
- affected scope
- Class II
- classification
- July 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2409-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2409-2018) was formally reported on July 18, 2018, with the manufacturer initiating the action on March 30, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Immuno-Mycologics, Inc is listed as the recalling firm, operating out of Norman, OK. Federal records list the affected scope as 875 units.
The documented reason for this recall is: Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results Distribution data in the federal record shows the product reached: On March 30, 2018, IMMY began issuing URGENT MEDICAL DEVICE RECALL notices to customers via email. Customers were advised on how to recognize that the device has failed. The following are Actions to be taken by th…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
875 units
Related Recalls
6
3 from same agency
Product description
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.
Reason for recall
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2409-2018 |
| Date reported | July 18, 2018 |
| Date initiated | March 30, 2018 |
| Recalling firm | Immuno-Mycologics, Inc |
| Firm location | Norman, OK |
| Affected scope | 875 units |
| Distribution | On March 30, 2018, IMMY began issuing URGENT MEDICAL DEVICE RECALL notices to customers via email. Customers were advised on how to recognize that the device has failed. The following are Actions to be taken by the customer/user: " … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2409-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF). The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.. Recalled by Immuno-Mycologics, Inc. Units affected: 875 units.
Why was this product recalled? ▼
Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2018. Severity: Moderate. Recall number: Z-2409-2018.
Where was the recalled product distributed? ▼
Distribution: On March 30, 2018, IMMY began issuing URGENT MEDICAL DEVICE RECALL notices to customers via email. Customers were advised on how to recognize that the device has failed. The following are Actions to be taken by the customer/user: " You may continue using the affected lots. Any testing performed on defective strips should be considered invalid and should be repeated. " Please immediately notify lab personnel who are running the test to look for defective strips (as seen by fast wicking and/or very weak control lines). " Please immediately complete the Acknowledgement and Receipt Form even if you do not have any affected stock remaining and submit via email to: customerservice@immy.com. " Ensure relevant staff members are informed of this recall, including relevant clinicians. " If you have supplied any potentially affected product to another organization, please advise that organization of this recall and notify IMMY. " In case product is in transit, display this letter in a prominent place for one month. Should you need a replacement kit, you will need to return your affected inventory. Instructions will be provided by customer service on how to return kits to IMMY. If you have any questions, contact IMMYs Quality Assurance Department by calling 1-405-360-4669 Monday through Friday 8:30 AM to 5:00 PM Central Standard Time..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2409-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 18, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.