Z-1132-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- January 11, 2021
- Termination Date
- December 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,274,272 strips (Updated 3/15/2021 added 69,168 strips)
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.
Distribution Pattern
Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.
Code Information
Catalog #:L016000109048 Lot #: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261) (Updated 3/15/2021) 5000323 (GM2000354), 6000142 (GM2000296), 6000100 (GM2000322)