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All product recalls associated with CELLTRION USA INC.
Total Recalls
5
Past Year
0
Class I (Serious)
0
Most Recent
Apr 2022
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Kits were labeled with incorrect expiration dates.
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.