FDA Medical devices recall ·
myQA iON recall
- Recall number
- Z-1703-2025
- Date
- (initiated April 1, 2025)
- Company / brand
- IBA Dosimetry GmbH
Bahnhofstr. 5, Schwarzenbruck, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 84 units (9US, 75 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
myQA iON; Article Number: MQ10-000;
Why was it recalled?
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Article Number: MQ10-000; UDI-DI: EIBAMQ010000;
Distribution
Worldwide - US Nationwide distribution in the states of AL, AR, FL, GA, KS, MD, OK and the countries of Algeria, Austria, Belgium, Czech Republic, Denmark, France, Germany, Ireland, Italy, Morocco, Norway, Poland, Slovakia, Spain, Israel, Kazakhstan, Kosovo, Libya, South Africa, Turkey, United Kingdom, Switzerland, Argentina, Brazil, Mexico, APAC: Indonesia, Japan, Peoples Republic of China, Philippines, South Korea, Thailand.
States: Alabama Arkansas Florida Georgia Kansas Maryland Oklahoma
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1703-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.