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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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