Z-0664-2019Class II

Alinity i TSH Reagent Kit, List Number 07P4830

Name: Z-0664-2019 Alinity i TSH Reagent Kit, List Number 07P4830
Creator: Abbott Ireland Diagnostics Division
Published: 2018-11-21
License: https://open.fda.gov/license/

Abbott Ireland Diagnostics Division / initiated 2018-11-21 / Terminated / root cause: manufacturing process

FDA source

Abbott Ireland Diagnostics Division began a recall of Alinity i TSH Reagent Kit, List Number 07P4830 on 2018-11-21. FDA classified it as Class II and gives the reason as "Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0664-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-21
Posted: 2018-12-22
Terminated: 2021-04-01
Recalling firm: Abbott Ireland Diagnostics Division
Product: Alinity i TSH Reagent Kit, List Number 07P4830
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall by letter on 11/21/2018. The notice explained the problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units. The units will be replaced.
Quantity in commerce: 678 units
Distribution: AR, FL, GA, MD, OK, VA
Product codes and lots: UDI/Lot Numbers: (01)00380740131159 (17)190710(10)90061UI00 / 90061UI00 (01)00380740131159 (17) 190827(10) 91526UI00 / 91526UI00 (01)00380740131159 (17)190924(10)92291UI00 / 92291UI00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0664-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0664-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0665-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0666-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0667-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0668-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22
Z-0669-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22

Product code JLW

K983442Class IIAbbott Architect TshAbbott Laboratories / cleared 1998-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)