Simplexa COVID-19 Direct, REF: MOL4150 recallZ-1209-2023 · DiaSorin Molecular LLC · initiated Jan 30, 2023

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-1209-2023

Status

Open, Classified

Initiated by the company

Jan 30, 2023

Posted by the FDA

Mar 3, 2023

Recalling firm

DiaSorin Molecular LLC

Quantity

90142

Product code

QJR

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 COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

Devices named in this recall

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

• Simplexa COVID-19 Direct MOL4150

  Diasorin Molecular LLC · Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
  1 recall1 report

Other products in the same recall event

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

• Z-1210-2023 · Open, Classified
  Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.