Home / Recalls / Phadia Ab / Z-1907-2019

Z-1907-2019 Class II Terminated

Recalled by Phadia Ab — Uppsala, N/A

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

Other recalls by Phadia Ab

  • Z-0783-2024 Class II — EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vit (May 24, 2023)
  • Z-2397-2019 Class II — Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully inte (July 9, 2019)
  • Z-1276-2018 Class II — Phadia Prime software, article number 12-4101-00, as used in combination with th (November 20, 2017)
  • Z-0697-2016 Class II — EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intend (December 28, 2015)