Uppsala, N/A, Sweden
Phadia Ab recalls
4 recalls recorded since 2018, most recently on 24 May 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 May 2023
- Reason
- Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0783-2024
- EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Terminated Class II Medical devices
- Recall started
- 9 July 2019
- Terminated
- 12 July 2022
- Reason
- code 7-102 Liquid Sensor Error
- Distribution
- US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2397-2019
- Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample
Terminated Class II Medical devices
- Recall started
- 10 May 2019
- Terminated
- 2 June 2020
- Reason
- Potential for reporting low assay results
- Distribution
- US Nationwide n the states of NJ, NY, MI, WV, TX including PR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1907-2019
- 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 a
Terminated Class II Medical devices
- Recall started
- 20 November 2017
- Terminated
- 6 March 2019
- Reason
- We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
- Distribution
- US Distribution to the states of :TX, VA, NJ, MA, IN, GA, UT, TN, CA, MS, NC, ME and OR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1276-2018
- Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.