N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cereb...

FDA Device Recall #Z-1289-2015 — Class III — January 15, 2015

Recall Summary

Recall Number Z-1289-2015
Classification Class III — Low risk
Date Initiated January 15, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Healthcare Diagnostics, Inc.
Location Newark, DE
Product Type Devices
Quantity 26

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.

Distribution Pattern

Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.

Lot / Code Information

Catalog # OQAC11, lots 44018, 44019 and 44042, expiration 4/3/2015

Other Recalls from Siemens Healthcare Diagnostics, Inc.

Recall # Classification Product Date
Z-1484-2026 Class II Atellica CH Urine Albumin (UAlb). Material Numb... Jan 20, 2026
Z-0491-2026 Class II IMMULITE 2000 Oak Mix Specific Allergen; Sieme... Oct 6, 2025
Z-0492-2026 Class II 3gAllergy Specific IgE Universal Kit; Kit Comp... Oct 6, 2025
Z-0493-2026 Class II Food Panel 3 Specific Allergen; Siemens Materi... Oct 6, 2025
Z-0366-2026 Class II Assay: IMMULITE 2000 Intact PTH; Test Code: iP... Sep 22, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.