Phadia US Inc Recall 87161
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
Phadia US Inc Recall 87161 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1107-2021 |
| Event ID | 87161 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 365 kits US |
| Recall Reason | 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). |
| Device Classification | 20210217 |
| Device Code Info | Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406 |
| Center Classification Date | 20210211 |
| Recall Initiation Date | 20201214 |
| Recalling Firm | Phadia US Inc |
| Initial Notification | Letter |
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