The Recall Desk
HighFDA (Devices)·Z-0162-2022·Announced 2021-10-27

COVID-19 Diagnostic Control Pack Recalled for Unapproved Raw Materials

DiaSorin Molecular is recalling the SIMPLEXA COVID-19 Positive Control Pack due to unapproved raw materials in manufacturing that may cause delayed amplification signals during testing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with a functional defect in a diagnostic control product. While no illnesses or deaths have been reported, the use of unapproved raw materials poses a risk of harm by potentially affecting COVID-19 test reliability and accuracy, meeting the criteria for high-risk products where injury has not yet been reported.

Plain-English summary

The FDA is overseeing the recall of the SIMPLEXA COVID-19 Positive Control Pack (REF MOL4160, UDI: 20816101027051), an in vitro diagnostic control product manufactured by DiaSorin Molecular LLC. Approximately 1,690 kits were affected and distributed worldwide, including throughout the United States, Canada, and Italy.

The recall was initiated because unapproved raw materials were used in the manufacturing of the control pack. These materials have the potential to cause delayed amplification signals, which could affect the performance and reliability of the diagnostic control.

The affected product lots are identified by the following lot numbers and expiration dates: 12175N (expires 11/30/2021), 12722N (expires 01/31/2022), X12122N (expires 01/31/2022), and X12724N (expires 08/31/2022). Laboratories with these lots should discontinue use.

The recalled product

Product
SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
Manufacturer
DiaSorin Molecular LLC
Category
Medical Device — Diagnostic Control / COVID-19 Testing
Hazard
Affected units
1,690

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #/Expiration Date: 12175N/11.30.2021
  • 12722N/01.31.2022
  • X12122N/01.31.2022
  • X12724N/08.31.2022

Distribution

Distributed nationwide across the United States.

The notice also names 34 states specifically:

Related recalls

Same manufacturer · DiaSorin Molecular LLC

See all →