Z-0895-2018 Class II Terminated
FDA device recall Z-0895-2018 was initiated by Instrumentation Laboratory Co. on August 2, 2017 and is designated Class II. 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 pro… The recall status is terminated (terminated March 29, 2019). Affected quantity: 14,894 kits.
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.