Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported May 18, 2016
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
Siemens Healthcare Diagnostics, Inc. recalled ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CL… — a low-severity action.
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CL… was recalled by Siemens Healthcare Diagnostics, Inc. in May 18, 2016. Reason: The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies th…. Check the official notice for the remedy. Verify recall #Z-1615-2016 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this low-severity FDA Devices recall — The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies th….
- Low
- severity level
- Class III
- classification
- May 18, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1615-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1615-2016) was formally reported on May 18, 2016, with the manufacturer initiating the action on March 30, 2016. 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 Tarrytown, NY. Federal records list the affected scope as US: 442 units; Foreign: 3237 units.
The documented reason for this recall is: The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, C…. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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.
Affected scope
US: 442 units; Foreign: 3237 units
Related Recalls
6
6 from same agency
Product description
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Reason for recall
The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1615-2016 |
| Date reported | May 18, 2016 |
| Date initiated | March 30, 2016 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Tarrytown, NY |
| Affected scope | US: 442 units; Foreign: 3237 units |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denma… |
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-1615-2016) 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? ▼
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: US: 442 units; Foreign: 3237 units.
Why was this product recalled? ▼
The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Low. Recall number: Z-1615-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1615-2016) 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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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 18, 2016.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.