# FDA recall Z-2470-2020

> **Siemens Healthcare Diagnostics Inc.** · Class II · device recall initiated 2020-05-15.

## Product

Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.

## Reason for recall

Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially  causing  liquid waste can leak onto the floor, creating a slip and fall hazard

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of AE, AO, AR, AT, AU, AZ, BA, BD, BE, BG, BH, BO, BR, BS, BY, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GP, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KZ, LB, LT, LU, LV, LY, ME, MK, MM, MQ, MT, MU, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, SY, TH, TN, TR, TT, TW, UA, UY, VE  VN, ZA.

## Key facts

- **Recall number:** Z-2470-2020
- **Recalling firm:** Siemens Healthcare Diagnostics Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-15
- **Report date:** 2020-07-08
- **Termination date:** 2022-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Flanders, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2470-2020

## Citation

> AI Analytics. FDA recall Z-2470-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2470-2020. Source: US FDA. Licensed CC0.

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