ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114...
FDA Device Recall #Z-1486-2018 — Class II — February 21, 2018
Recall Summary
| Recall Number | Z-1486-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 21, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Healthcare Diagnostics, Inc |
| Location | East Walpole, MA |
| Product Type | Devices |
| Quantity | SMN 10310443 (1-pack/100 tests) - 13257 kits; SMN 10315696 (5-pack/500 tests) - 9930 kits |
Product Description
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Reason for Recall
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Distribution Pattern
US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mexico, Morocco, Myamar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan,Thailand, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay, Uzbekistan,Vatican City, and Vietnam.
Lot / Code Information
SMN 10310443 (1-pack/100 tests): Lot 71804174, Exp 2018-Apr-27, UDI (01)00630414461298(10)71804174(17)20180427 Lot 73838174, Exp 2018-Apr-27, UDI (01)00630414461298(10)73838174(17)20180427 Lot 88601174, Exp 2018-Apr-27, UDI (01)00630414461298(10)88601174(17)20180427 Lot 94549174, Exp 2018-Apr-27, UDI (01)00630414461298(10)94549174(17)20180427 Lot 23904176, Exp 2018-Aug-30, UDI (01)00630414461298(10)23904176(17)20180830 Lot 24439176, Exp 2018-Aug-30, UDI (01)00630414461298(10)24439176(17)20180830 Lot 31842176, Exp 2018-Aug-30, UDI (01)00630414461298(10)31842176(17)20180830 Lot 42051176, Exp 2018-Aug-30, UDI (01)00630414461298(10)42051176(17)20180830 Lot 54008176, Exp 2018-Aug-30, UDI (01)00630414461298(10)54008176(17)20180830 SMN 10315696 (5-pack/500 tests): Lot 71229174, Exp 2018-Apr-27, UDI (01)00630414461304(10)71229174(17)20180427 Lot 73455174, Exp 2018-Apr-27, UDI (01)00630414461304(10)73455174(17)20180427 Lot 84113174, Exp 2018-Apr-27, UDI (01)00630414461304(10)84113174(17)20180427 Lot 91568174, Exp 2018-Apr-27, UDI (01)00630414461304(10)91568174(17)20180427 Lot 23903176, Exp 2018-Aug-30, UDI (01)00630414461304(10)23903176(17)20180830 Lot 24944176, Exp 2018-Aug-30, UDI (01)00630414461304(10)24944176(17)20180830 Lot 41442176, Exp 2018-Aug-30, UDI (01)00630414461304(10)41442176(17)20180830 Lot 46735176, Exp 2018-Aug-30, UDI (01)00630414461304(10)46735176(17)20180830
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.