ARCHITECT recallZ-0325-2024 · Sentinel CH SpA · initiated Sep 29, 2023
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 Sentinel CH SpA 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
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
FDA root cause category: Under Investigation by firm
What the company is doing
A Field Safety Notice letter dated 9/29/23 was sent to customers. Actions to be taken: " Discontinue the use of and destroy any remaining inventory of the affected lots listed above of IRON for use with ARCHITECT REF 6K95-41, REF 6K95-30 and Alinity c Iron Reagent Kit REF 08P3920 according to your laboratory procedures. " Review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results. Results should always be assessed in conjunction with the patient's medical history, clinical examination and other biochemical tests as suggested by clinical guidelines. " Complete and return the Abbott Customer Reply Form. " Please retain this letter for your laboratory records. Transmission of this Field Safety Notice: This notice needs to be passed on to all those who need to be aware within your organization or to any organization/individuals where the potentially affected devices have been transferred. If you or any of your customers have any questions regarding this information, please contact your local area Abbott Customer Service.
Recall details
- Recall number
- Z-0325-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 29, 2023
- Posted by the FDA
- Nov 17, 2023
- Recalling firm
- Sentinel CH SpA
- Quantity
- 4394 kits
- Product code
- JIY
- Distribution
- Worldwide - US Nationwide distribution.
Product description
IRON assay, Reference Numbers 6K95-41 and 6K95-30
Code information (models, lots, serial numbers)
Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 00380740010911; Lot Numbers: 21058Y600, 21101Y600, 30918Y600
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARCHITECT 6K95-30Abbott Laboratories · Photometric method, iron (non-heme)1 recall0 reports
- ARCHITECT 6K95-41Abbott Laboratories · Photometric method, iron (non-heme)1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93298).
- Z-0326-2024 · Open, ClassifiedAlinity c Iron Reagent, Reference Number 08P3920
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.
How recalls are matched to devices · Editorial policy · Report an error on this page