Alere iScreen single drug detection kits may not consistently detect all drugs due to enzyme failures. Affected kits include Buprenorphine, Barbiturate, Oxycodone, and other drug tests. Consumers should check their kit's model number and 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.
Alere iScreen single drug detection kits may not consistently detect all drugs because of enzyme failures. This means some drugs could be missed in testing, which could lead to inaccurate results. Affected kits include specific drug tests for buprenorphine, barbiturates, oxycodone, and others.
The kits use immunoassay enzymes that failed to work properly, causing inconsistent detection of calibrators and other compounds. This means the tests might not detect all drugs at the levels stated on the label, leading to inaccurate results.
People who own or use Alere iScreen single drug detection kits for home testing. Those most at risk are individuals who rely on these kits for accurate drug screening results.
Check the model number on the kit, which starts with X11-IS1 followed by a code like BUP-DX for buprenorphine or BAR-DX for barbiturates. All lots within the expiry date are affected.
Look for the model number on the kit, which starts with X11-IS1 followed by a code like BUP-DX for buprenorphine or BAR-DX for barbiturates.
The recall does not require discarding the kits; it only advises checking the model number to see if they are affected.
The kits test for specific drugs including buprenorphine, barbiturates, oxycodone, benzodiazepines, methamphetamine, amphetamines, ecstasy, methadone, morphine, marijuana, tricyclic antidepressants, and phencyclidine.
Yes, all lots within the expiry date are affected by this recall.
We’ve drafted a message you can send Alere to request your refund or repair — edit it as you like.
Subject: Recall Z-3029-2020 — Alere Alere Hello, I own a Alere that is covered by recall Z-3029-2020 from Alere. 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.
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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.
