FDA recall Z-2596-2018

Product

EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

Reason for recall

Underfilled reagent well that could lead to incorrect results

Distribution

Domestic - MD Internationally - AE, AU , CZ, DE, DZ, ES, FR, GB, HK , IE, IT, NO, RO & SA

Key facts

Status

Terminated

Initiation date

2018-05-28

Report date

2018-08-08

Termination date

2019-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

KOELN, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2596-2018