FDA Devices recall · Reported March 25, 2015
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.
Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042.
Siemens Healthcare Diagnostics, Inc. recalled N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in hum… - a low-severity action.
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in hum… was recalled by Siemens Healthcare Diagnostics, Inc. in March 25, 2015. Reason: Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when usi…. Check the official notice for the remedy. Verify recall #Z-1289-2015 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this low-severity FDA Devices recall-Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when usi….
- Low
- severity level
- 26 units
- affected scope
- Class III
- classification
- March 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1289-2015 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.
Reason for recall
Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1289-2015 |
| Date reported | March 25, 2015 |
| Date initiated | January 15, 2015 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Newark, DE |
| Affected scope | 26 |
| Distribution | Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada. |
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-1289-2015) 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
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Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026