# FDA recall Z-1906-2019

> **Bio-Rad Laboratories, Inc** · Class II · device recall initiated 2019-01-10.

## Product

EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

## Reason for recall

User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the  customer's Laboratory Information System (LIS).

## Distribution

Distribution was nationwide to medical facilities, including to Puerto Rico.  There was also government/military distribution.  There was no foreign distribution.

## Key facts

- **Recall number:** Z-1906-2019
- **Recalling firm:** Bio-Rad Laboratories, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-10
- **Report date:** 2019-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1906-2019

## Citation

> AI Analytics. FDA recall Z-1906-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1906-2019. Source: US FDA. Licensed CC0.

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