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Recall Observatory FDA recall evidence

Device product

Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Z-0895-2018

August 02, 2017

Class II

Product summary

Firm
Instrumentation Laboratory Co.
Event
Event 79165
Status
Terminated
Classification
Class II
Quantity
14,894 kits
Official record key
device-enforcement:Z-0895-2018

Official wording

Reason: 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.

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

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.