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Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655 recallZ-1210-2023 · DiaSorin Molecular LLC · initiated Jan 30, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DiaSorin Molecular LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

On 01/30/2023, correction notices were distributed to customers via in-person site visits. Customers were asked to do the following: 1) Discontinue use of affected devices using affected assay definitions. 2) Customers can contact the recalling firm to replace affected kits. The firm can also provide assistance with inventory reconciliation/destruction, and if needed, assistance with potential instrument/lab decontamination. 3) Any sample result with an error code (EC510, EC515, RNA IC, Insufficient Specimen Volume) should be retested following the Instructions for Use. 4) If leakage is suspected, the spillage should be removed and the instrument surface should be decontaminated. Ensure the practice of Good Laboratory Procedures including regular cleaning. 5) This recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Notify others within your network that may have remaining inventory of those kits. 5) Complete and return the acknowledgement and receipt form and return to the recalling firm's Technical Service department at [email protected] Product in the field with the previous high spin assay definitions are being recalled and replaced with current products with the current reduced spin assay definitions. Customers with questions are encouraged to email (see above) or call Technical Service at (800) 838-4548, option 3, Monday - Friday, 7:00am to 5:00pm (Pacific Time)

Recall details

Recall number
Z-1210-2023
Status
Open, Classified
Initiated by the company
Jan 30, 2023
Posted by the FDA
Mar 3, 2023
Recalling firm
DiaSorin Molecular LLC
Quantity
4142
Product code
OCC
FDA submissions
K201505
Distribution
US Nationwide distribution including in the states of NJ, ME, ND, IL, MI, FL, GA, AZ, MA, CA, MO, SD, MN, PA, OH, VT, NE, WI, CO, DC, VA, TX, NH, IN, IA, MD, NC, AL, NY, KY, WV, RI, KS, NM, OK, WA, SC, CT, TN, NV, LA.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 20816101026962. Product REF/Lot/Reaction Mix REF/Lot: MOL2655/13648N/MOL2656/13649N, MOL2655/13882N/MOL2656/15164N, MOL2655/15279N/MOL2656/15280N

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91504).

Sources and updates

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