Meridian Premier Cryptococcal Antigen Test Recalled for Stability Issues
Meridian Bioscience is recalling Premier Cryptococcal Antigen kits because an enzyme reagent may not maintain stability, potentially causing false negative results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk diagnostic test where the hazard is the potential for false negative results, which is a risk-of-harm product scenario where injury has not yet been reported.
Plain-English summary
Meridian Bioscience Inc is recalling 184 units of the PREMIER Cryptococcal Antigen enzyme immunoassay (EIA), Catalog Number 602096. The affected lots are 602096K089, 602096K090, and 602096K091. This product is a screening or semi-quantitative test system used to detect capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid.
The recall was initiated because an enzyme reagent included in the kit is not maintaining stability through the claimed product expiration. This instability results in the potential for false negative results when the test is used with patient specimens and the positive control.
The products were distributed worldwide, including nationwide in the United States to the states of AK, CA, CO, DE, IL, KS, KY, LA, MD, MO, NC, ND, NJ, NY, SC, TX, and VA, as well as to India and Italy. Healthcare facilities and laboratories should stop using the affected lots and contact Meridian Bioscience for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Meridian Bioscience Inc
- Affected units
- 184
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: 602096K089
- 602096K090
- 602096K091
Distribution
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