CLASS II Device recall · Reported 9 Feb 2022 · FDA Enforcement Report
Cryptococcal Antigen Lateral Flow Assay, Immy recalled
Immuno-Mycologics is recalling Cryptococcal Antigen Lateral Flow Assay, Immy, Lateral Flow Assay for the Detection of, distributed nationwide in the US. The recall was initiated on 3 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0545-2022
- FDA event ID
- 89370
- Recalling firm
- Immuno-Mycologics, Norman, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jan 2022
- FDA classified
- 31 Jan 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 3 Jan 2022 | Recall initiated by company | |
| 31 Jan 2022 | Classified by FDA | +28 days |
| 9 Feb 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
Where it was distributed
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriMississippiNorth CarolinaNorth DakotaNebraska
Questions about this recall
Why was it recalled?
The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples with positive test results may be false positives, which may cause some patients to initiate unnecessary anti-fungal therapy. Samples with negative test results are NOT affected.
Which lots are affected?
F1021035 and F1021036
Where was it sold?
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Immuno-Mycologics
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Immy, Myco DDR Trident, Bulk Neutralization Buffer B ( mL) recalled | Immuno-Mycologics | Other | Nationwide |
| Device | CLASS II | Candida ID Antigen, REAG, AG recalled by Immuno-Mycologics | Immuno-Mycologics | Other | Nationwide |
| Device | CLASS II | Histoplasma Immunodiffusion (ID) Antigen recalled by Immuno-Mycologics | Immuno-Mycologics | Other | Nationwide |
| Device | CLASS II | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) recalled | Immuno-Mycologics | Potency & Assay | OK |
| Device | CLASS II | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) recalled | Immuno-Mycologics | Potency & Assay | Nationwide |
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