FDA recall Z-1077-2018

Product

Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;

Reason for recall

The diagnostic test kit may produce invalid test runs which may delay test results.

Distribution

Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.

Key facts

Status

Terminated

Initiation date

2017-11-02

Report date

2018-03-28

Termination date

2018-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Berlin, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1077-2018