Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 28, 2020
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Quidel Corporation recalled Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow im… - a moderate-severity action.
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow im… was recalled by Quidel Corporation in October 28, 2020. Reason: Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to…. Check the official notice for the remedy. Verify recall #Z-0124-2021 with the FDA Devices before acting.
The recall
Quidel Corporation issued this moderate-severity FDA Devices recall-Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to….
- Moderate
- severity level
- 11K units
- affected scope
- Class II
- classification
- October 28, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0124-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0124-2021) was formally reported on October 28, 2020, with the manufacturer initiating the action on September 17, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Quidel Corporation is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 10537.
The documented reason for this recall is: Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the speci… Distribution data in the federal record shows the product reached: U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO.. 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
10537
Related Recalls
6
3 from same agency
Product description
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
Reason for recall
Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0124-2021 |
| Date reported | October 28, 2020 |
| Date initiated | September 17, 2020 |
| Recalling firm | Quidel Corporation |
| Firm location | San Diego, CA |
| Affected scope | 10537 |
| Distribution | U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO. |
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-0124-2021) 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? ▼
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.. Recalled by Quidel Corporation. Units affected: 10537.
Why was this product recalled? ▼
Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0124-2021.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0124-2021) 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 October 28, 2020. 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.