Greer Laboratories recalls specific hyper sensitivity pneumonitis test kits (lot 389592) due to potential false negatives from stability issues. Affected kits may give incorrect results, requiring retesting.
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 (lot 389592) because stability testing showed reduced reactivity, which could cause false negative results. This means the test might not detect infections properly, leading to incorrect health conclusions.
The test kit's stability issues caused reduced reactivity, meaning it might not work properly over time. This could lead to false negative results where infections are not detected, potentially delaying proper treatment.
People who own or use the specific hyper-sensitivity pneumonitis test kit (lot 389592) are affected. Those testing for pneumonitis may be at risk of incorrect results.
Check for the lot number 389592 on the kit's label. The product is a hyper-sensitivity pneumonitis test kit with expiration date 6/12/2023.
Look for the lot number 389592 on the test kit to confirm if it is affected.
The recall is due to stability issues that could cause false negative results, meaning infections might not be detected properly.
Check the lot number on the kit; if it's 389592, contact Greer Laboratories for guidance.
No, the recall is for potential false negatives, not physical harm. The risk is only incorrect 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-0348-2023 — Greer Laboratories Greer Laboratories Hello, I own a Greer Laboratories that is covered by recall Z-0348-2023 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.
