Z-2208-2019Class II

Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent...

Name: Z-2208-2019 Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent...
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: design

FDA source

Abbott Ireland Diagnostics Division began a recall of Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the... 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 design.

Recall record

Recall number: Z-2208-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-21
Posted: 2019-08-07
Terminated: 2021-03-25
Recalling firm: Abbott Ireland Diagnostics Division
Product: Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.
Product code: DBF Ferritin, Antigen, Antiserum, Control
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: design
FDA root cause: Device Design
Action: The firm, Abbott, initiated the recall by a "Product Recall Urgent - Immediate Action Required" letter dated 11/21/2018 to its consignees. The letter explained the product, problem and provided instruction on how to inspect the reagent cartridges for defect. The consignee was directed to discard the defective units, use an alternate lot of the product if available; manually inspect each reagent cartridge in inventory before use; complete and return the Customer Reply Form via FAX #: 18007770051 or email: [email protected]. Even if you no longer have the instrument(s), please return the completed Customer Reply Form so that we can appropriately update our customer database; If you have forwarded the product to other laboratories, please inform them of this Product Recall and provide to them a copy of this letter; and retain this letter for your laboratory records. The units will be replaced. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
Quantity in commerce: 216 units
Distribution: US Distribution to states of: AR, FL, GA, MD, OK and VA.
Product codes and lots: UDI/ Lot Numbers: (01)00380740131487 (17)190730(10)91532UI00/91532UI00, (01)00380740131487 (17)190905(10)93238UI00/93238UI00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2208-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2208-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07

Product code DBF

K983759Class IIAbbott Architect FerritinAbbott Laboratories / cleared 1998-12-07

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)