bioM¿rieux NucliSENS easyMAG Lysis Buffer ref — Class II medical device recall Z-0443-2019
Terminated recall by bioMerieux, Inc., reported 2018-11-21, distributed in CA, FL, GA, MD, MI, MN, NC, NJ…. Some eluates become colored because of remaining hemoglobin in the eluate.
| Recall number | Z-0443-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2018-10-08 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2021-05-21 |
| Distributed | CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, WI |
| Countries outside the US | AT, AU, BD, BE, CH, CO, DE, EE, ES, FR, GB, IL, IN, IT, JP, NL, PT, SE, SG, ZA |
| Quantity | 268 |
| Lot numbers | Z019EA1LB |
| Model numbers | 280134 |
| Expiration dates | 2019-05-28 |
Product
bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
Reason for recall
Some eluates become colored because of remaining hemoglobin in the eluate.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0443-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.