The Binding Site Group recalls OPTILITE IgM Kit (REF: NK012.OPT.A) due to potential calibration errors that could lead to false patient results and delayed testing.
There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
The Binding Site Group recalls their OPTILITE IgM Kit (REF: NK012.OPT.A) because it may not validate properly, causing false test results and delays in patient care. This could affect lab users who rely on the kit for accurate diagnostics.
The kit may report calibration values outside the specified ranges, leading to false patient results. This could cause delays in testing and potentially incorrect diagnoses if not addressed.
Lab technicians and healthcare providers using the OPTILITE IgM Kit for patient testing are most at risk. The recall affects kits purchased with lot number 422251.
Check for the kit reference number NK012.OPT.A and lot number 422251 on the product packaging. The recall applies to kits sold with this specific lot number.
Verify the product reference number NK012.OPT.A and lot number 422251 on the kit packaging.
The kit may not validate properly, causing calibration values to report outside specified ranges, which could lead to false patient results and delayed testing.
Check the product reference number and lot number on the packaging. If it matches NK012.OPT.A and lot 422251, contact The Binding Site Group for further instructions.
The recall does not mention any risk of serious injury; the hazard is limited to potential false results and testing delays.
We’ve drafted a message you can send The Binding Site Group to request your refund or repair — edit it as you like.
Subject: Recall Z-1327-2020 — The Binding Site Group The Binding Site Group Hello, I own a The Binding Site Group that is covered by recall Z-1327-2020 from The Binding Site Group. 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.
