Z-0958-2023Class III

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Name: Z-0958-2023 Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Creator: Abbott Laboratories
Published: 2022-11-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-11-24 / Open, Classified / root cause: manufacturing process

FDA source

Abbott Laboratories began a recall of Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels on 2022-11-24. FDA classified it as Class III and gives the reason as "Reaction vessels may contain a potential contaminant that could affect their optical performance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0958-2023
Classification: Class III
Status: Open, Classified
Initiated: 2022-11-24
Posted: 2023-01-17
Recalling firm: Abbott Medical
Product: Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Product code: DHA System, Test, Human Chorionic Gonadotropin
Reason for recall: Reaction vessels may contain a potential contaminant that could affect their optical performance.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 11/24/22, the recalling firm phoned customers and informed them of the recall using a phone script. On the same day, the phone call was followed by an email that restated the information in the phone script and included a Customer Reply form. Customers were asked to discontinue use and destroy the impacted inventory according to their laboratory procedures. If customers forwarded the product to other laboratories, they were asked to inform them of this Product Recall and complete and return the Customer Reply form, which can be returned to [email protected]. The reply form asked customers to record the number of boxes destroyed. If you have any questions, contact QA Manager, Post Market Surveillance at 224-668-0343 or email: [email protected].
Quantity in commerce: 70 cases
Distribution: US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
Product codes and lots: UDI-DI/Lots: 00380740129026/000586790 and 000586879

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0958-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0958-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-17

Product code DHA

K170317Class IIAlinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories / cleared 2017-10-23

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)