Recall Z-0732-2019 ยท MDU Antigen, Elisa, Cryptococcus
Meridian Bioscience Inc
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).
| Date | Dec 17, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | Urgent: Voluntary Medical Device Recall notification letters dated 12/17/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken. The letters instructed customers to review inventory for affected lots, forward the letter to any customers, contact the firm replacement product, complete the response form. For questions contact Meridian's Technical Service Department by telephone at 800-343-3858 or 513-271-3700 or by facsimile 513-272-5432. |
| Quantity | 184 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904393 | PREMIER-CRYPTOCOCCAL ANTIGEN Meridian Diagnostics, Inc., Jan 25, 1991 |