Z-3038-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 7, 2020
- Initiation Date
- August 18, 2020
- Termination Date
- September 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12, 100 units
Product Description
MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G.", MTPA-6MBAU/ "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G."
Reason for Recall
Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
Distribution Pattern
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Code Information
ALL Lots Within Expiry