Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported July 7, 2021
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detecti…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Quidel Corporation recalled Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent - a critical-severity action.
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent was recalled by Quidel Corporation in July 7, 2021. Reason: In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct val…. Check the official notice for the remedy. Verify recall #Z-1928-2021 with the FDA Devices before acting.
The recall
Quidel Corporation issued this critical-severity FDA Devices recall-In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct val….
- Critical
- severity level
- Class I
- classification
- July 7, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1928-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1928-2021) was formally reported on July 7, 2021, with the manufacturer initiating the action on April 27, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Quidel Corporation is listed as the recalling firm, operating out of Athens, OH. Federal records list the affected scope as 29,787 kits (96 results/kit).
The documented reason for this recall is: In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. T… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom.. 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
29,787 kits (96 results/kit)
Related Recalls
6
3 from same agency
Product description
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Reason for recall
In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1928-2021 |
| Date reported | July 7, 2021 |
| Date initiated | April 27, 2021 |
| Recalling firm | Quidel Corporation |
| Firm location | Athens, OH |
| Affected scope | 29,787 kits (96 results/kit) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom. |
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-1928-2021) 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.
- 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? ▼
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent. Recalled by Quidel Corporation. Units affected: 29,787 kits (96 results/kit).
Why was this product recalled? ▼
In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Critical. Recall number: Z-1928-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1928-2021) 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.
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 July 7, 2021. 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.