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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urinalysis controls (assayed and unassayed)
Product CodeJJW
Regulation Number 862.1660
Device Class 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Jan-03-2023
2 Beckman Coulter, Inc. III Apr-21-2022
3 Cardinal Health Inc. II May-20-2020
4 Randox Laboratories Ltd. III Sep-23-2019
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