Z-1907-2019 Class II Terminated
FDA device recall Z-1907-2019 was initiated by Phadia Ab on May 10, 2019 and is designated Class II. Reason for recall: Potential for reporting low assay results The recall status is terminated (terminated June 2, 2020). Affected quantity: 30 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 10, 2019
- Initiation Date
- May 10, 2019
- Termination Date
- June 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 kits
Product Description
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.
Reason for Recall
Potential for reporting low assay results
Distribution Pattern
US Nationwide n the states of NJ, NY, MI, WV, TX including PR
Code Information
UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085