Tecan recalls Cortisol Saliva Luminescence Immunoassay kits that may produce 1.3-1.8x higher cortisol readings than NIST standard, affecting adrenal disorder diagnosis.
Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.
Tecan recalls certain cortisol saliva test kits that may give 1.3-1.8 times higher cortisol results than the standard. This could lead to incorrect diagnosis of adrenal disorders if used without proper calibration.
The test kits may produce 1.3-1.8 times higher cortisol values than the NIST standard. This could cause inaccurate results when diagnosing adrenal disorders, but does not pose immediate physical danger.
People using the recalled Cortisol Saliva Luminescence Immunoassay kits for adrenal disorder testing. Those with adrenal conditions may be at higher risk of misdiagnosis.
Check for lot numbers RE62119 (LCL129 or LCL133), RE62111 (LCL130), or OUS lots 131 and 132. The kits were sold in the US with specific expiration dates.
Look for lot numbers RE62119 (LCL129 or LCL133), RE62111 (LCL130), or OUS lots 131 and 132 on the packaging.
The test kits may produce 1.3-1.8 times higher cortisol values than the NIST standard, which could lead to inaccurate adrenal disorder diagnoses.
The recall record does not specify a remedy, so no action is required beyond checking the lot number.
The recall indicates potential for inaccurate results, but does not mention physical harm or injury risks.
We’ve drafted a message you can send Tecan to request your refund or repair — edit it as you like.
Subject: Recall Z-2923-2018 — Tecan Tecan Hello, I own a Tecan that is covered by recall Z-2923-2018 from Tecan. 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.
