Waltham, MA, United States
LumiraDx recalls
5 recalls recorded since 2018, most recently on 25 April 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 April 2023
- Reason
- Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1970-2023
- SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Terminated Class III Medical devices
- Recall started
- 23 September 2022
- Terminated
- 13 December 2024
- Reason
- Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0135-2023
- LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrumen
Terminated Class II Medical devices
- Recall started
- 24 June 2022
- Terminated
- 10 May 2024
- Reason
- Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
- Distribution
- Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1451-2022, Z-1450-2022
- LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
- LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Terminated Class II Medical devices
- Recall started
- 3 February 2021
- Terminated
- 13 July 2022
- Reason
- Two lots of test strips failed QC testing using blank buffer due to false positives.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Terminated Class II Medical devices
- Recall started
- 11 January 2021
- Terminated
- 3 December 2021
- Reason
- 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
- Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1132-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.