Z-0325-2024Class II

IRON assay, Reference Numbers 6K95-41 and 6K95-30

Name: Z-0325-2024 IRON assay, Reference Numbers 6K95-41 and 6K95-30
Creator: Sentinel CH SpA
Published: 2023-09-29
License: https://open.fda.gov/license/

Sentinel CH SpA / initiated 2023-09-29 / Open, Classified

FDA source

Sentinel CH SpA began a recall of IRON assay, Reference Numbers 6K95-41 and 6K95-30 on 2023-09-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0325-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-29
Posted: 2023-11-17
Recalling firm: Sentinel CH SpA
Product: IRON assay, Reference Numbers 6K95-41 and 6K95-30
Product code: JIY Photometric Method, Iron (Non-Heme)
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 4394 kits
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 00380740010911; Lot Numbers: 21058Y600, 21101Y600, 30918Y600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0325-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0325-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17
Z-0326-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17

Product code JIY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)