Recall Z-0457-2022— DiaSorin Molecular LLC
Class II · Ongoing
Class II FDA medical device recall by DiaSorin Molecular LLC, initiated 2021-11-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455. Reason: A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned..
- Recalling firm
- DiaSorin Molecular LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-19
- Firm location
- Cypress, CA, United States
Product description
Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
Reason for recall
A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.
Data sourced from openFDA. This site is unofficial and independent of the FDA.