Recall Z-1132-2021— LumiraDx
Class II · Terminated
Class II FDA medical device recall by LumiraDx, initiated 2021-01-11, terminated 2021-12-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- LumiraDx
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-11
- Terminated
- 2021-12-03
- Firm location
- Waltham, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.