Severity
Low
FDA Devices recall · Reported November 26, 2014
Stability of the ADVIA Centaur Cleaning Solution is not assured
Siemens Healthcare Diagnostics, Inc recalled ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitr… - a low-severity action.
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitr… was recalled by Siemens Healthcare Diagnostics, Inc in November 26, 2014. Reason: Stability of the ADVIA Centaur Cleaning Solution is not assured. Check the official notice for the remedy. Verify recall #Z-0214-2015 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc issued this low-severity FDA Devices recall-Stability of the ADVIA Centaur Cleaning Solution is not assured.
Sourced from official FDA Devices enforcement records. Verify recall #Z-0214-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0214-2015) was formally reported on November 26, 2014, with the manufacturer initiating the action on September 12, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc is listed as the recalling firm, operating out of East Walpole, MA. Federal records list the affected scope as 4645 (12 pk).
The documented reason for this recall is: Stability of the ADVIA Centaur Cleaning Solution is not assured Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam.. 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.
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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
4645 (12 pk)
Related Recalls
6
3 from same agency
ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP instruments, and therefore does not have independent Instructions for Use (IFU). Information regarding use of the Cleaning Solution is contained in the owner's manual for the instruments.
Stability of the ADVIA Centaur Cleaning Solution is not assured
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0214-2015 |
| Date reported | November 26, 2014 |
| Date initiated | September 12, 2014 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Firm location | East Walpole, MA |
| Affected scope | 4645 (12 pk) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada. Grerat Britain, Saudi Arabia, Nepal, and Viet Nam. |
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.
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.
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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 26, 2014. 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.