Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Apti...

FDA Device Recall #Z-2087-2016 — Class II — May 11, 2016

Recall Summary

Recall Number Z-2087-2016
Classification Class II — Moderate risk
Date Initiated May 11, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Healthcare Diagnostics Inc.
Location Brookfield, CT
Product Type Devices
Quantity 487

Product Description

Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.

Reason for Recall

Premature bucket failures

Distribution Pattern

Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV.

Lot / Code Information

All serial numbers are affected.

Other Recalls from Siemens Healthcare Diagnostics Inc.

Recall # Classification Product Date
Z-2469-2020 Class II Siemens IMMULITE 2000 Immunoassay System - In v... May 15, 2020
Z-2470-2020 Class II Siemens IMMULITE 2000 XPi Immunoassay System - ... May 15, 2020
Z-1885-2016 Class II Dimension Vista 500 Intelligent Lab System runn... Mar 24, 2016
Z-1886-2016 Class II Dimension Vista 1500 Intelligent Lab System run... Mar 24, 2016
Z-0459-2016 Class II Reagent Management System (RMS) Dimension EXL ... Nov 10, 2015

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.