Siemens Healthcare recalls Dimension Vista LOCI 8 Calibrator lot 7CD076 due to increased calibration failures with Estradiol tests. Affected users should contact for replacement.
An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.
Siemens Healthcare is recalling its Dimension Vista LOCI 8 Calibrator lot 7CD076 because it can cause calibration errors with Estradiol tests. This means test results might be inaccurate, potentially leading to incorrect medical decisions.
The calibrator may cause more calibration failures or negative bias when used with Estradiol (E2) tests. This could lead to inaccurate test results, potentially affecting medical decisions.
Lab users who purchased or use the Dimension Vista LOCI 8 Calibrator lot 7CD076 for Estradiol testing are affected. Those handling hormone tests in clinical labs face the highest risk.
Check for the lot number 7CD076 on the calibrator's label. The product was sold with catalog number KC646 and was manufactured on April 1, 2018.
Reach out to Siemens Healthcare for a replacement or further instructions.
The recalled lot number is 7CD076.
It can cause increased calibration failures or negative bias with Estradiol tests, potentially leading to inaccurate results.
The official recall does not specify a fix; users should contact Siemens Healthcare for a replacement.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1184-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1184-2018 from Siemens Healthcare. 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.
