Recall Z-1107-2021
Phadia US Inc · initiated December 14, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406
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).
FDA-determined cause: Under Investigation by firm
Action taken
Phadia US Inc. (Initial Importer/Distributor) issued notification to consignees via phone and FedEx overnight delivery Dec. 17-18 . Letter states reason for recall, health risk and action to take: Customers are asked to perform the following steps: 1.Scrap EliA dsDNA Well lot BFA3Y/0142 and order a replacement free of charge 2. Assess test results from EliA dsDNA Well lot BFA3Y/0142 and determine if retesting of samples is warranted in accordance with internal operating procedures. 3. Complete the Acknowledgement Form in the Medical Device Field Safety Notice and return the response to the contact person described. Any questions concerning this issue, contact Phadia US Technical Support at 1-800-346-4364, option #2.
Details
- Recall number
- Z-1107-2021
- Initiated
- December 14, 2020
- Posted by FDA
- February 11, 2021
- Terminated
- August 4, 2022
- Product code
- LSW – Anti-Dna Antibody, Antigen And Control
- Quantity
- 365 kits US
- Distribution
- US Nationwide distribution.
- Recalling firm
- Phadia US Inc, Portage, MI