Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 5, 2016
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc recalled Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the foll… - a moderate-severity action.
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the foll… was recalled by Siemens Healthcare Diagnostics, Inc in October 5, 2016. Reason: Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the interna…. Check the official notice for the remedy. Verify recall #Z-2899-2016 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc issued this moderate-severity FDA Devices recall-Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the interna….
- Moderate
- severity level
- Class II
- classification
- October 5, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2899-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2899-2016) was formally reported on October 5, 2016, with the manufacturer initiating the action on August 8, 2016. It is classified under Moderate severity (Class II), 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 2,248 kits.
The documented reason for this recall is: Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization Distribution data in the federal record shows the product reached: Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China …. 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
2,248 kits
Related Recalls
6
3 from same agency
Product description
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Reason for recall
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2899-2016 |
| Date reported | October 5, 2016 |
| Date initiated | August 8, 2016 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Firm location | East Walpole, MA |
| Affected scope | 2,248 kits |
| Distribution | Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador… |
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-2899-2016) 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? ▼
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996). Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 2,248 kits.
Why was this product recalled? ▼
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2899-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - Nationwide Distribution including the countries of: Argentina Australia Brazil Canada Chile China Ecuador India Japan Korea Mexico Malaysia Peru Philippines Saudi Arabia Singapore Taiwan Vietnam South Africa.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2899-2016) 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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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 October 5, 2016. 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.