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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 kit (excludes hiv testing)
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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 CodeOFZ
Regulation Number 868.1100
Device Class 1

MDR Year MDR Reports MDR Events
2018 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 1 1
Leak/Splash 1 1
Incorrect Or Inadequate Test Results 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
Exposure to Body Fluids 1 1

Manufacturer Recall Class Date Posted
1 Medical Action Industries, Inc. 306 I May-12-2021