Food, drugs, devices › LumiraDx
Device recall: Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid pr
FDA enforcement event 87366 is a device recall by LumiraDx of Waltham, MA, initiated 3 Feb 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 13 Jul 2022. Initiation: voluntary: firm initiated. LumiraDx has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
LumiraDx, Waltham, MA.
Reason for recall
"Two lots of test strips failed QC testing using blank buffer due to false positives."
Distribution
"US nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1312-2021 | Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset. | 2186 devices | Class II | Terminated | 7 Apr 2021 |
Context
Other enforcement events for LumiraDx
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Apr 2023 | SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catal | Device | Class II | 1 |
| 23 Sep 2022 | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quali | Device | Class III | 1 |
| 24 Jun 2022 | LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip | Device | Class II | 2 |
| 11 Jan 2021 | LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 An | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Two lots of test strips failed QC testing using blank buffer due to false positives."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Jul 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.