Sentinel CH recalls Alinity c CRP Vario Calibrator Kit (ref 07P5605) due to incorrect vial labeling, which may prevent successful calibration of cardiac tests on Alinity c analyzers.
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
Sentinel CH is recalling Alinity c CRP Vario Calibrator Kit (ref 07P5605) because vials are incorrectly labeled. This can cause the instrument to warn that calibrators are incorrectly loaded, preventing successful calibration of cardiac tests.
The calibrator vials have incorrect labels, which causes the Alinity c analyzer to generate a warning message. This warning prevents the calibration process from completing successfully, potentially leading to inaccurate test results.
Users of the Alinity c CRP Vario Calibrator Kit (ref 07P5605) for cardiac CRP high sensitivity testing on Alinity c analyzers. Patients and healthcare providers using this kit for cardiac tests are most at risk.
Check for the product name 'Alinity c CRP Vario Calibrator Kit' with reference number 07P5605. The kit was sold with lot number 00681Y600.
Verify that the vials are correctly labeled for the Alinity c CRP Vario Calibrator Kit (ref 07P5605).
The calibrator vials have incorrect labels, which causes the Alinity c analyzer to warn that calibrators are incorrectly loaded, preventing successful calibration of cardiac tests.
Check the vial labels to ensure they are correctly labeled for the Alinity c CRP Vario Calibrator Kit (ref 07P5605). If labels are incorrect, stop using the kit and contact Sentinel CH for further instructions.
The recall record does not specify a fix or remedy for this issue.
We’ve drafted a message you can send Sentinel CH to request your refund or repair — edit it as you like.
Subject: Recall Z-0033-2022 — Sentinel CH Sentinel CH Hello, I own a Sentinel CH that is covered by recall Z-0033-2022 from Sentinel CH. 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.
