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Instrumentation Laboratory Recall 88930

Description: HemosIL ReadiPlasTin (20 mL), Part number 0020301400

Instrumentation Laboratory Recall 88930 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0276-2022
Event ID88930
Event DescriptionHemosIL ReadiPlasTin (20 mL), Part number 0020301400
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AZ, CA, IA, IL, KS, ME, MI, NC, NY, OK, SC, and VA. The countries of Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea.
Quantity5828 kits (310 US)
Recall ReasonThe firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
Device Classification20211201
Device Code InfoLot N0705526 UDI 08426950632887
Center Classification Date20211123
Recall Initiation Date20211013
Recalling FirmInstrumentation Laboratory
Initial Notification E-Mail
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