microStar Reader — Class II medical device recall Z-1349-2024
Completed recall by Landauer, reported 2024-03-27, distributed nationwide. Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to re
| Recall number | Z-1349-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Landauer, Glenwood, IL, United States |
| Recall initiated | 2024-02-08 |
| Classified | 2024-03-21 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CN, FR, GB, IN, JO, JP, KR, MX, MY, PE, PH, PK, SE, SG, TH, TR, TW, UY, VE, VN |
| Quantity | 975 units |
| Reason classes | software |
| Model numbers | 10015-000 |
Product
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
Reason for recall
Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.
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-1349-2024. 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.