FDA recall Z-1906-2019

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

Status

Ongoing

Initiation date

2019-01-10

Report date

2019-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Redmond, WA, United States

Primary source

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