Recall Z-1210-2023— DiaSorin Molecular LLC

Name: FDA recall Z-1210-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-30

Class II · Ongoing

Class II FDA medical device recall by DiaSorin Molecular LLC, initiated 2023-01-30. It names one FDA 510(k) clearance: K201505. Product: Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.. Reason: Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes..

Recalling firm: DiaSorin Molecular LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-01-30
Firm location: Cypress, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackDiasorin Molecular, LLC·cleared 2020-08-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

Reason for recall

Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.