Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10...
FDA Device Recall #Z-1564-2014 — Class II — March 25, 2014
Recall Summary
| Recall Number | Z-1564-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics, Inc |
| Location | East Walpole, MA |
| Product Type | Devices |
| Quantity | 49123 units |
Product Description
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems
Reason for Recall
Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland Finland France Fren.Polynesia Germany Great Britain Greece Guadeloupe Hungary Iceland Ireland Israel Italy Latvia Lithuania Luxembourg Malta Martinique Netherlands Norway Poland Portugal Qatar Reunion Romania Russian Fed. Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir.
Lot / Code Information
Kit Lots ending in and exp date: 219 Exp. Date 25 March, 2014; 222 Exp Date 12 May, 2014; 224 Exp Date 04 August, 2014; 225 Exp Date 04 August, 2014; 226 Exp Date 12 September, 2014; 227 Exp. Date 06 October, 2014
Other Recalls from Siemens Healthcare Diagnostics, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0124-2022 | Class II | Atellica IM 1300 Analyzer, SMN 11066001 | Sep 28, 2021 |
| Z-0125-2022 | Class II | Atellica IM 1600 Analyzer, SMN 11066000 | Sep 28, 2021 |
| Z-0196-2022 | Class II | ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Tes... | Sep 22, 2021 |
| Z-0195-2022 | Class II | Atellica IM SARS-CoV-2 Antigen Assay (100 Test ... | Sep 22, 2021 |
| Z-2425-2021 | Class II | Atellica IM BR 27.29 (BR) Assay 250 Test Kit- i... | Jul 6, 2021 |
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.