Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 9, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
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 the…
Celltrion USA INC recalled Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 - a critical-severity action.
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 was recalled by Celltrion USA INC in March 9, 2022. Reason: Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). …. Check the official notice for the remedy. Verify recall #Z-0680-2022 with the FDA Devices before acting.
The recall
Celltrion USA INC issued this critical-severity FDA Devices recall-Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). ….
- Critical
- severity level
- Class I
- classification
- March 9, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0680-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0680-2022) was formally reported on March 9, 2022, with the manufacturer initiating the action on December 2, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Celltrion USA INC is listed as the recalling firm, operating out of Jersey City, NJ. Federal records list the affected scope as 8080 kits originally distributed; 726 kits redistributed.
The documented reason for this recall is: 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 provide… Distribution data in the federal record shows the product reached: Distributed to TX.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8080 kits originally distributed; 726 kits redistributed
Related Recalls
6
3 from same agency
Product description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0680-2022 |
| Date reported | March 9, 2022 |
| Date initiated | December 2, 2021 |
| Recalling firm | Celltrion USA INC |
| Firm location | Jersey City, NJ |
| Affected scope | 8080 kits originally distributed; 726 kits redistributed |
| Distribution | Distributed to TX. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0680-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02. Recalled by Celltrion USA INC. Units affected: 8080 kits originally distributed; 726 kits redistributed.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Critical. Recall number: Z-0680-2022.
Where was the recalled product distributed? ▼
Distribution: Distributed to TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0680-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 9, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.