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

FDA device recall Z-1210-2023 · posted 2023-03-03 · Open, Classified

Recall details

Recalling firm

DiaSorin Molecular LLC

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.

Action taken

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 technicalinfo.molecular@diasorin.com 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)

Root cause

Device Design

Status

Open, Classified

Product code

OCC

Quantity affected

4142

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

Date initiated

2023-01-30

Date posted

2023-03-03

Location

Cypress, CA

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