LumiraDx Recall 87259
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.
LumiraDx Recall 87259 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1132-2021 |
| Event ID | 87259 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom. |
| Quantity | 3,274,272 strips (Updated 3/15/2021 added 69,168 strips) |
| Recall 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. |
| Device Classification | 20210224 |
| Device Code Info | Catalog #:L016000109048 Lot #: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261) (Updated 3/15/2021) 5000323 (GM2000354), 6000142 (GM2000296), 6000100 (GM2000322) |
| Center Classification Date | 20210217 |
| Recall Initiation Date | 20210111 |
| Recalling Firm | LumiraDx |
| Initial Notification | |
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