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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood specimen collection convenience kit (excludes hiv)
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodePQD
Regulation Number 862.1675
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2022 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Manufacturing, Packaging or Shipping Problem 16 16
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LetsGetChecked Inc. II Mar-03-2023
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