Reported Feb 17, 2021 · Terminated
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA…
Phadia US Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Phadia US Inc · 4169 Commercial Ave · Portage, MI · 49002-9701
Is this the product you have?
- EliA dsDNA Well - Product Usageintended 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 Number14-5500-01
- Lot codes and dates
- Carrier Lot NumberBFA3Y
- Kit Lot Number
0142(UDI): 07333066019406
- Amount recalled
- 365 kits US
Where it was sold
- Nationwide
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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