Home / Recalls / Phadia Ab / Z-2397-2019

Z-2397-2019 Class II Terminated

Recalled by Phadia Ab — Uppsala, N/A

Recall Details

Product Type
Devices
Report Date
September 4, 2019
Initiation Date
July 9, 2019
Termination Date
July 12, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
387 Instruments

Product Description

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 and reagent handling to processing of results.

Reason for Recall

code 7-102 Liquid Sensor Error

Distribution Pattern

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

Code Information

All Serial Numbers; Unique Device Identifier (UDI): 07333066001005

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  • Z-1907-2019 Class II — EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is inten (May 10, 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)