# FDA recall Z-1486-2018

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2018-02-21.

## Product

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

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.

## Key facts

- **Recall number:** Z-1486-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-21
- **Report date:** 2018-05-02
- **Termination date:** 2019-05-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1486-2018

## Citation

> AI Analytics. FDA recall Z-1486-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1486-2018. Source: US FDA. Licensed CC0.

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