Home / Recalls / CELLTRION USA INC / Z-0953-2022

Z-0953-2022 Class I Terminated

Recalled by CELLTRION USA INC — Jersey City, NJ

Recall Details

Product Type
Devices
Report Date
May 4, 2022
Initiation Date
April 1, 2022
Termination Date
June 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,632 kits

Product Description

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

Reason for Recall

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

Distribution Pattern

US Nationwide distribution.

Code Information

All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.

Other recalls by CELLTRION USA INC

  • Z-0731-2022 Class II — Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 (February 25, 2022)
  • Z-0659-2022 Class I — Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 (December 28, 2021)
  • Z-0680-2022 Class I — Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 (December 2, 2021)
  • Z-0558-2022 Class II — Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dispos (December 1, 2021)