Recall Z-3038-2020— Ameditech Inc
Class II · Terminated
Class II FDA medical device recall by Ameditech Inc, initiated 2020-08-18, terminated 2024-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Ameditech Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-18
- Terminated
- 2024-09-30
- Firm location
- San Diego, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.