Z-1149-2018 Class II Terminated
FDA device recall Z-1149-2018 was initiated by Medica Corporation on November 21, 2017 and is designated Class II. Reason for recall: The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying… The recall status is terminated (terminated August 20, 2020). Affected quantity: 392.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- November 21, 2017
- Termination Date
- August 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 392
Product Description
Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of the work list. The major interferant for Lipase is the Triglycerides (TRIG) assay since one of the reagents contains lipase as an active ingredient.
Reason for Recall
The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.
Distribution Pattern
Worldwide and US Distribution.
Code Information
Lots 16279, 17045 and 17215