Alinity recallZ-0958-2023 · Abbott Laboratories · initiated Nov 24, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reaction vessels may contain a potential contaminant that could affect their optical performance.
FDA root cause category: Material/Component Contamination
What the company is doing
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].
Recall details
- Recall number
- Z-0958-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 24, 2022
- Posted by the FDA
- Jan 17, 2023
- Recalling firm
- Abbott Laboratories
- Quantity
- 70 cases
- Product code
- DHA
- FDA submissions
- K170317
- Distribution
- US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV
Product description
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Code information (models, lots, serial numbers)
UDI-DI/Lots: 00380740129026/000586790 and 000586879
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Alinity 06P1401Abbott Laboratories · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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