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
Reported: February 17, 2021 Initiated: December 14, 2020 #Z-1107-2021
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).
Details
- Recalling Firm
- Phadia US Inc
- Units Affected
- 365 kits US
- Distribution
- US Nationwide distribution.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Phadia US Inc. Units affected: 365 kits US.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-1107-2021.
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