Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 24, 2021
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnece…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
LumiraDx recalled LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Resp… - a moderate-severity action.
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Resp… was recalled by LumiraDx in February 24, 2021. Reason: Observations of potential false positive results in the specified lots. Use of these test strips may result i…. Check the official notice for the remedy. Verify recall #Z-1132-2021 with the FDA Devices before acting.
The recall
LumiraDx issued this moderate-severity FDA Devices recall-Observations of potential false positive results in the specified lots. Use of these test strips may result i….
- Moderate
- severity level
- Class II
- classification
- February 24, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1132-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1132-2021) was formally reported on February 24, 2021, with the manufacturer initiating the action on January 11, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. LumiraDx is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 3,274,272 strips (Updated 3/15/2021 added 69,168 strips).
The documented reason for this recall is: Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine. Distribution data in the federal record shows the product reached: Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, 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 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
3,274,272 strips (Updated 3/15/2021 added 69,168 strips)
Related Recalls
6
3 from same agency
Product description
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
Reason for recall
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1132-2021 |
| Date reported | February 24, 2021 |
| Date initiated | January 11, 2021 |
| Recalling firm | LumiraDx |
| Firm location | Waltham, MA |
| Affected scope | 3,274,272 strips (Updated 3/15/2021 added 69,168 strips) |
| Distribution | Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, 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-1132-2021) 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? ▼
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.. Recalled by LumiraDx. Units affected: 3,274,272 strips (Updated 3/15/2021 added 69,168 strips).
Why was this product recalled? ▼
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2021. Severity: Moderate. Recall number: Z-1132-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1132-2021) 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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Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 February 24, 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.