Randox recalls CK MB Calibrator model CK2393 (lot 441:0CK) due to potential 6% calibration shift affecting test accuracy. Affected units may need recalibration or replacement.
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.
Randox is recalling CK MB Calibrator model CK2393 (lot 4410CK) because using it with the new calibration value causes a 6% shift in test results. This could lead to inaccurate patient test results if not corrected.
The calibrator's calibration value has been realigned, causing a 6% shift in test results when used with the new value. This shift affects both quality control samples and patient samples, potentially leading to inaccurate test outcomes.
Lab technicians and healthcare facilities using Randox CK MB Calibrator model CK2393 (lot 4410CK) for blood testing. Those handling patient samples or quality controls are most at risk of inaccurate results.
Check for the model CK2393 with lot number 4410CK on the device or packaging. The product was sold with GTIN 05055273201451.
Verify the current calibration value on the device matches the manufacturer's specifications for model CK2393.
Randox realigned the CK-MB Calibrator (model CK2393, lot 4410CK), causing a 6% shift in test results when calibrated with the new value.
Using the recalibrated value may cause inaccurate test results for both quality controls and patient samples.
Check if your device has model CK2393 and lot number 4410CK. If so, verify the calibration value and contact Randox for guidance.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1097-2022 — Randox Randox Hello, I own a Randox that is covered by recall Z-1097-2022 from Randox. 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.
