# FDA recall Z-2483-2020

> **Ortho Clinical Diagnostics** · Class II · device recall initiated 2020-05-20.

## Product

VITROS 5600 Integrated System - Refurbished	Software Versions	3.3.3 and below    Product Code: 6802915   Unique Identifier: 10758750007110

## Reason for recall

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

## Distribution

US Nationwide Distribution  Foreign:  Country  AR  AU  BR  CA  CL  CN  CO  DO  FR  ID  IN  JP  KR  MX  MY  NP  PE  PH  SG  TH  TT  VE  VN

## Key facts

- **Recall number:** Z-2483-2020
- **Recalling firm:** Ortho Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-20
- **Report date:** 2020-07-08
- **Termination date:** 2022-11-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2483-2020

## Citation

> AI Analytics. FDA recall Z-2483-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2483-2020. Source: US FDA. Licensed CC0.

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