The Recall Desk
HighFDA (Devices)·Z-1209-2023·Announced 2023-03-15

COVID-19 Diagnostic Test Kits May Leak, Causing Invalid Results

DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.

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 no reported injuries or illnesses. The product defect (leakage in amplification discs causing contamination and invalid test results) qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DiaSorin Molecular LLC is recalling approximately 90,142 units of the Simplexa COVID-19 Direct test kits (REF: MOL4150) following discovery of a defect in the direct amplification discs component.

The direct amplification discs may leak during use, which can cause cross-contamination, invalid test results, and error codes. This defect could compromise the reliability of COVID-19 diagnostic testing.

The affected kits were distributed nationwide, with units identified in at least 35 U.S. states. Laboratories and healthcare facilities that use these kits should cease usage immediately.

Customers in possession of affected kits (identified by specific lot numbers available from the FDA recall notice) should contact DiaSorin Molecular LLC for return instructions and replacement options.

The recalled product

Product
Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2
Manufacturer
DiaSorin Molecular LLC
Category
Medical Device — COVID-19 Diagnostic
Hazard
  • leakage
  • contamination
  • cross-contamination
  • invalid-test-results

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 (20)

  • MOL4150/US14913/MOL4151/US14063
  • MOL4150/US13952/MOL4151/US14065
  • MOL4150/US13955/MOL4151/US14086
  • MOL4150/US13959/MOL4151/US14088
  • MOL4150/US13956/MOL4151/US14087
  • MOL4150/US13960/MOL4151/US14093
  • MOL4150/US13961/MOL4151/US14094
  • MOL4150/US13973/MOL4151/US13732
  • MOL4150/US13974/MOL4151/US13736
  • MOL4150/US14006/MOL4151/US13738
  • MOL4150/US14004/MOL4151/US15064
  • MOL4150/US14005/MOL4151/US13737
  • MOL4150/US14008/MOL4151/US14100
  • MOL4150/US14007/MOL4151/US14099
  • MOL4150/US14010/MOL4151/US14102
  • MOL4150/US14011/MOL4151/US14103
  • MOL4150/US14012/MOL4151/US15290
  • MOL4150/US14018/MOL4151/US14111
  • MOL4150/US14009/MOL4151/US14101
  • MOL4150/US14017/MOL4151/US14109

Distribution

Distributed nationwide across the United States.

Related recalls

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