Celltrion DiaTrust COVID-19 Rapid Test distributed to unqualified facilities
Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits distributed to facilities without valid CLIA certification. The tests were distributed nationwide from December 2021 through February 2022.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which indicates serious potential for adverse health consequences. No illnesses, injuries, or deaths have been reported.
Plain-English summary
Celltrion USA Inc. is recalling 12,632 units of the Celltrion DiaTrust COVID-19 Ag Rapid Test (Reference No. CT-P60 D-2 02) due to improper distribution. The tests were distributed to customers without valid Clinical Laboratory Improvement Amendments (CLIA) identification. CLIA certification is federally required for any laboratory that performs diagnostic testing on human specimens.
The affected kits were distributed nationwide between December 2021 and February 2022. All lots of this product distributed during this period are included in the recall. The FDA has classified this as a Class I recall, indicating a serious potential health risk from use of the product in uncertified settings.
If you received these test kits and do not have valid CLIA certification, do not use the product. Contact Celltrion USA Inc. for instructions on returning the recalled kits. Facilities with valid CLIA certification should verify they received only properly distributed product.
The recalled product
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Manufacturer
- CELLTRION USA INC
- Category
- Medical Device — Diagnostic Test
- Affected units
- 12,632
Distribution
Distributed nationwide across the United States.
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