CLASS II Device recall · Reported 23 Jan 2019 · FDA Enforcement Report
Premier Cryptococcal Antigen recalled by Meridian Bioscience
Meridian Bioscience is recalling Premier Cryptococcal Antigen, distributed nationwide in the US. The recall was initiated on 17 Dec 2018 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-0732-2019
- FDA event ID
- 81787
- Recalling firm
- Meridian Bioscience, Cincinnati, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2018
- FDA classified
- 14 Jan 2019
- Reported
- 23 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Dec 2018 | Recall initiated by company | |
| 14 Jan 2019 | Classified by FDA | +28 days |
| 23 Jan 2019 | 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
An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
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
PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).
Where it was distributed
Worldwide Distribution - US Nationwide in the states of: AK, CA, CO, DE, IL, KS, KY, LA, MD, MO, NC, ND, NJ, NY, SC, TX, and VA. The products were distributed to the following foreign countries: India and Italy.
Nationwide AlaskaCaliforniaColoradoDelawareIllinoisKansasKentuckyLouisianaMarylandMissouriNorth CarolinaNorth DakotaNew JerseyNew YorkSouth CarolinaTexasVirginia
Questions about this recall
Why was it recalled?
An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
Which lots are affected?
Lot Numbers: 602096K089, 602096K090, 602096K091
Where was it sold?
Worldwide Distribution - US Nationwide in the states of: AK, CA, CO, DE, IL, KS, KY, LA, MD, MO, NC, ND, NJ, NY, SC, TX, and VA. The products were distributed to the following foreign countries: India and Italy.
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.
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