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Changchun WanCheng Bio Electron Co., Ltd

Country not established

Devices
0
FDA recalls
1111 ongoing

No devices from this company are in the catalogue yet.

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 11
  • 2026 0

Showing the 10 most recent of 11 recalls.

  • 2025

    • 22 Nov 2025 Z-1257-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1258-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1259-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1260-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1261-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1262-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1263-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1264-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1265-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
    • 22 Nov 2025 Z-1266-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.
Show all 11 recalls

  • 2025

    • 22 Nov 2025 Z-1267-2026 Class II Ongoing Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention. Distribution: US Nationwide distribution in the states of TX, GA, CA.