Data Foundry

Medical device recalls 2022

NUCLISENS easyMAG Magnetic Silica — Class II medical device recall Z-1564-2022

Ongoing recall by bioMerieux, Inc., reported 2022-08-31, distributed in AR, AZ, CA, CT, FL, IL, IN, KS…. There is a potential of no result leading to possible delayed result due to contamination of extraction reagen

Recall numberZ-1564-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmbioMerieux, Inc., Durham, NC, United States
Recall initiated2022-07-20
Classified2022-08-23
Reported by FDA2022-08-31
DistributedAR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, VA
Quantity1,301 kits
UPC / GTIN / UDI-DI03573026139339
Model numbers280133
Expiration dates2022-11-28, 2022-12-28, 2023-01-28

Product

NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

Reason for recall

There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.

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-1564-2022. 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.