Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 29, 2023
IRON assay, Reference Numbers 6K95-41 and 6K95-30
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% fo…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Sentinel Ch SpA recalled IRON assay, Reference Numbers 6K95-41 and 6K95-30 - a moderate-severity action.
IRON assay, Reference Numbers 6K95-41 and 6K95-30 was recalled by Sentinel Ch SpA in November 29, 2023. Reason: A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the posit…. Check the official notice for the remedy. Verify recall #Z-0325-2024 with the FDA Devices before acting.
The recall
Sentinel Ch SpA issued this moderate-severity FDA Devices recall-A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the posit….
- Moderate
- severity level
- Class II
- classification
- November 29, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0325-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0325-2024) was formally reported on November 29, 2023, with the manufacturer initiating the action on September 29, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Sentinel Ch SpA is listed as the recalling firm, operating out of Milan, N/A. Federal records list the affected scope as 4394 kits.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4394 kits
Related Recalls
6
3 from same agency
Product description
IRON assay, Reference Numbers 6K95-41 and 6K95-30
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0325-2024 |
| Date reported | November 29, 2023 |
| Date initiated | September 29, 2023 |
| Recalling firm | Sentinel Ch SpA |
| Firm location | Milan, N/A |
| Affected scope | 4394 kits |
| Distribution | Worldwide - US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0325-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
IRON assay, Reference Numbers 6K95-41 and 6K95-30. Recalled by Sentinel Ch SpA. Units affected: 4394 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0325-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0325-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 29, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.