Ameditech recalls MicroScreen devices that may not consistently detect calibrators and compounds due to enzyme failure. Affected units include all lots within expiry date.
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.
Ameditech is recalling MicroScreen devices that may not consistently detect all calibrators and compounds because of enzyme failures. This could lead to inaccurate test results if used for medical or laboratory purposes.
The devices use enzymes that have failed to perform correctly, meaning they might not detect all calibrators and compounds at the levels stated on the label. This could result in inaccurate test results if the devices are used for medical or laboratory purposes.
Users of MicroScreen devices for medical or laboratory testing who have the affected model numbers. Those using the devices for critical diagnostic purposes may be at higher risk.
Check for MicroScreen AMP300/BZO200/COC300/MET300/OPI300/THC50 models with the AMT Item Number MSCA-6MBAU. All lots within the expiry date are affected.
Identify if your MicroScreen device is one of the affected models: AMP300/BZO200/COC300/MET300/OPI300/THC50 with AMT Item Number MSCA-6MBAU.
The recall does not require immediate stop use; the devices may still function but could produce inaccurate results.
The recall record does not specify a remedy, so contact Ameditech for guidance on next steps.
Only the specific MicroScreen models with AMT Item Number MSCA-6MBAU are affected, as stated in the recall.
We’ve drafted a message you can send Ameditech to request your refund or repair — edit it as you like.
Subject: Recall Z-3037-2020 — Ameditech Ameditech Hello, I own a Ameditech that is covered by recall Z-3037-2020 from Ameditech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
