Greer Laboratories recalls specific hyper sensitivity pneumonitis test kits due to potential false negative results from decreased reactivity in some lots. Affected kits may not detect infections correctly.
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.
Greer Laboratories is recalling a specific hyper sensitivity pneumonitis test kit that could give false negative results. This means the test might miss infections when they're actually present.
The test kit may not work properly because the reactivity decreased, leading to false negative results. This means infections could be missed when the test is used.
People who own or use the specific hyper sensitivity pneumonitis test kit with lot number 389591 are affected. Those who rely on this test for accurate infection detection are most at risk.
Check for the lot number 389591 on the test kit packaging. The product is a gel diffusion kit for hyper sensitivity pneumonitis testing, sold with an expiration date of June 12, 2023.
Look for lot number 389591 on the test kit packaging to confirm if it's affected.
The recall is due to decreased reactivity in some lots that could lead to false negative results, meaning infections might not be detected correctly.
Check the lot number on the packaging. If it's 389591, contact Greer Laboratories for further instructions.
No, the recall is for potential false negative results, not physical harm. The risk is only to accurate test results.
We’ve drafted a message you can send Greer Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0347-2023 — Greer Laboratories Greer Laboratories Hello, I own a Greer Laboratories that is covered by recall Z-0347-2023 from Greer Laboratories. 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.
