MAUDE manufacturer profile

HOLOGIC, INC. · MKZ

MAUDE profile for Dna Probe, Nucleic Acid Amplification, Chlamydia

Key facts

Manufacturer HOLOGIC, INC.
Manufacturer group HOLOGIC, INC.
Product code MKZ
Product code name Dna Probe, Nucleic Acid Amplification, Chlamydia

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, False Positive Result, No Consequences Or Impact To Patient, Nonstandard Device, Data Problem, Misassembled, Off-Label Use Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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