Home / Recalls / Instrumentation Laboratory Co. / Z-0895-2018

Z-0895-2018 Class II Terminated

Recalled by Instrumentation Laboratory Co. — Bedford, MA

Recall Details

Product Type
Devices
Report Date
March 14, 2018
Initiation Date
August 2, 2017
Termination Date
March 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,894 kits

Product Description

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 Pattern

Worldwide Distribution - US Nationwide

Code Information

Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.

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