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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1107-2021
Event ID87161
Event DescriptionEliA 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 TypeDevices
DistributionUS Nationwide distribution.
Quantity365 kits US
Recall ReasonDecreased 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 Classification20210217
Device Code InfoCarrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406
Center Classification Date20210211
Recall Initiation Date20201214
Recalling FirmPhadia US Inc
Initial Notification Letter
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