FDA Devices recall · Reported May 11, 2016
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number: 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specim
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
Ab Sciex recalled Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 320… - a moderate-severity action.
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 320… was recalled by Ab Sciex in May 11, 2016. Reason: Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an inc…. Check the official notice for the remedy. Verify recall #Z-1586-2016 with the FDA Devices before acting.
The recall
Ab Sciex issued this moderate-severity FDA Devices recall-Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an inc….
- Moderate
- severity level
- 279 units
- affected scope
- Class II
- classification
- May 11, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1586-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number: 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Reason for recall
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1586-2016 |
| Date reported | May 11, 2016 |
| Date initiated | February 24, 2016 |
| Recalling firm | Ab Sciex |
| Firm location | Framingham, MA |
| Affected scope | 279 |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED K… |
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-1586-2016) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026