# FDA recall Z-1389-2021

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2021-03-05.

## Product

ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US,  automated hematology analyzer     Software Versions 6.10 and 6.11

## Reason for recall

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Albania, Algeria, Angola, Argentina, Australia,   Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium,   Benin, Bosnia Herzeg., Botswana, Brazil, Bulgaria, Burkina, Faso, Cambodia, Canada, Chile, Colombia, Croatia, Cura¿ao  Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland,   France, Fren.Polynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq,   Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait,   Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mali  Malta, Martinique, Mexico, Namibia, Netherlands, Norway,   Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania,   Russian Fed., San Marino, Saudi Arabia, Senegal, Serbia,   Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden,   Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United 

## Key facts

- **Recall number:** Z-1389-2021
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-05
- **Report date:** 2021-04-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2021

## Citation

> AI Analytics. FDA recall Z-1389-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1389-2021. Source: US FDA. Licensed CC0.

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