Recall Z-1349-2024— Landauer
Class II · Completed
Class II FDA medical device recall by Landauer, initiated 2024-02-08. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Landauer
- Classification
- Class II
- Status
- Completed
- Initiated
- 2024-02-08
- Firm location
- Glenwood, IL, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.