Home / Recalls / Abbott Gmbh & Co. KG / Z-0789-2019

Z-0789-2019 Class II Terminated

Recalled by Abbott Gmbh & Co. KG — Wiesbaden, N/A

Recall Details

Product Type
Devices
Report Date
February 6, 2019
Initiation Date
December 20, 2018
Termination Date
September 19, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
434 units

Product Description

Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

Reason for Recall

Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer. The foaming/bubbling is a result of an improper calibration of the pump s operating speed.

Distribution Pattern

Worldwide Distribution

Code Information

(a) Serial Numbers: Ai01001 - Ai01455, Ai01457, Ai01459 (b) all Serial Numbers (c) all Serial Numbers

Other recalls by Abbott Gmbh & Co. KG

  • Z-2701-2020 Class II — Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series sof (June 19, 2020)
  • Z-2401-2020 Class II — Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. (May 12, 2020)
  • Z-2117-2020 Class II — ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are (April 24, 2020)
  • Z-1728-2020 Class II — ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. (March 9, 2020)
  • Z-1580-2020 Class II — LN 3R70-01; software version 2.6.2 and earlier. The software is used with the A (January 24, 2020)
  • Z-0574-2020 Class II — ARCHITECT HAVAB-G Calibrator, REF 6L27-01 (November 7, 2019)
  • Z-0575-2020 Class II — Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostic (October 23, 2019)
  • Z-0543-2020 Class II — Alinity ci Level Sensor, Bulk Solution (September 16, 2019)
  • Z-0545-2020 Class II — Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution (September 16, 2019)
  • Z-0544-2020 Class II — Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution (September 16, 2019)