Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 11, 2023
Detect Covid-19 Test Product/Model Number: 21205
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of suppor…
Detect Headquarters recalled Detect Covid-19 Test Product/Model Number: 21205 - a moderate-severity action.
Detect Covid-19 Test Product/Model Number: 21205 was recalled by Detect Headquarters in January 11, 2023. Reason: There is an increased chance that the tests from affected lots may give false negative results. Health risks …. Check the official notice for the remedy. Verify recall #Z-0879-2023 with the FDA Devices before acting.
The recall
Detect Headquarters issued this moderate-severity FDA Devices recall-There is an increased chance that the tests from affected lots may give false negative results. Health risks ….
- Moderate
- severity level
- Class II
- classification
- January 11, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0879-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0879-2023) was formally reported on January 11, 2023, with the manufacturer initiating the action on December 8, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Detect Headquarters is listed as the recalling firm, operating out of Guilford, CT. Federal records list the affected scope as 10142 (US); 960 OUS.
The documented reason for this recall is: There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of… Distribution data in the federal record shows the product reached: Domestic distribution nationwide. Foreign distribution to Hong Kong.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10142 (US); 960 OUS
Related Recalls
6
3 from same agency
Product description
Detect Covid-19 Test Product/Model Number: 21205
Reason for recall
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0879-2023 |
| Date reported | January 11, 2023 |
| Date initiated | December 8, 2022 |
| Recalling firm | Detect Headquarters |
| Firm location | Guilford, CT |
| Affected scope | 10142 (US); 960 OUS |
| Distribution | Domestic distribution nationwide. Foreign distribution to Hong Kong. |
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-0879-2023) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Detect Covid-19 Test Product/Model Number: 21205. Recalled by Detect Headquarters. Units affected: 10142 (US); 960 OUS.
Why was this product recalled? ▼
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0879-2023.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution nationwide. Foreign distribution to Hong Kong..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0879-2023) 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.
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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 January 11, 2023. 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.