DiaSorin Molecular LLC: Medical Device Recall in 2023 - (Recall #: Z-2153-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452

Product Classification:

Class II

Date Initiated: June 14, 2023

Date Posted: July 26, 2023

Recall Number: Z-2153-2023

Event ID: 92559

Reason for Recall:

There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.

Status: Ongoing

Product Quantity: 4,7878 units

Code Information:

MOL1455 UDI-DI: 01-30816101025092 MOL1455 kit lot codes: P17044N P17052N P17301N P17302N P17303N P17304N P17305N P17306N P17351N P17352N P17353N P17354N P17614N P17625N P17650N P17652N P17653N P17654N P17687N P17688N P17731N MOL1452 disc lot codes: P15886N P16794N P16795N P16796N P16883N P16885N P17022N P17056N P17057N P17047N P17023N P17176N P17177N P17294N P17178N P17295N P17359N P17362N P17296N P17361N P17046N

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and the countries of Bangladesh, Canada, Israel, Italy.

Voluntary or Mandated:

Voluntary: Firm initiated