Z-1107-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- December 14, 2020
- Termination Date
- August 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 365 kits US
Product Description
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
Reason for Recall
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
Distribution Pattern
US Nationwide distribution.
Code Information
Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406