FDA recall Z-0895-2018

Product

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Reason for recall

Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.

Distribution

Worldwide Distribution - US Nationwide

Key facts

Status

Terminated

Initiation date

2017-08-02

Report date

2018-03-14

Termination date

2019-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0895-2018