Reported Mar 9, 2022 · Terminated
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Celltrion USA Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CELLTRION USA INC · 1 Evertrust Plz Ste 1207 · Jersey City, NJ · 07302-3087
Is this the product you have?
Celltrion DiaTrust COVID-19 Ag Rapid TestReference No. CT-P60 D-2 02
- Lot codes and dates
- Lot COVGCCM0008
- Amount recalled
- 243 kits (6,075 tests)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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