Siemens Healthcare recalls Syva EMIT II Plus 6-Acetylmorphine 1000mL kits with incorrect calibrator level in calibration steps. No remedy specified in recall notice.
Incorrect calibrator level listed in qualitative calibration steps
Siemens Healthcare is recalling Syva EMIT II Plus 6-Acetylmorphine 1000mL kits because the calibration steps list an incorrect calibrator level. This could lead to inaccurate test results if used without correction.
The calibration steps in the kit list an incorrect calibrator level. This could cause test results to be inaccurate if the kit is used without correcting the level. Inaccurate results might lead to incorrect medical decisions.
Users of the Syva EMIT II Plus 6-Acetylmorphine 1000mL kits for laboratory testing. Lab technicians and healthcare professionals using these kits are most at risk of inaccurate test results.
Check for the Syva EMIT II Plus 6-Acetylmorphine 1000mL kits with catalog number 9R129UL and serial number 10481483. All lots of this product are affected.
Verify the catalog number 9R129UL and serial number 10481483 on the kit packaging.
The recall notice does not specify a remedy.
Check for the catalog number 9R129UL and serial number 10481483 on the kit packaging.
The recall notice does not specify a remedy.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1799-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1799-2018 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.
