Z-1312-2021 Class II Terminated
FDA device recall Z-1312-2021 was initiated by LumiraDx on February 3, 2021 and is designated Class II. Reason for recall: Two lots of test strips failed QC testing using blank buffer due to false positives. The recall status is terminated (terminated July 13, 2022). Affected quantity: 2186 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 7, 2021
- Initiation Date
- February 3, 2021
- Termination Date
- July 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2186 devices
Product Description
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.
Reason for Recall
Two lots of test strips failed QC testing using blank buffer due to false positives.
Distribution Pattern
US nationwide distribution.
Code Information
catalog #: L001000330001