Chromsystems recalls specific lots of 6PLUS1 Multilevel Saliva Calibrator Sets due to potential inaccurate cortisol and cortisone test results. Affected units may need replacement.
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Chromsystems is recalling certain lots of their 6PLUS1 Multilevel Saliva Calibrator Sets because they might give incorrect cortisol and cortisone test results. This could lead to inaccurate health monitoring for patients using the kit.
The calibrator lots may not meet stability criteria, which means the test results for cortisol and cortisone could be higher than they should be. This could lead to incorrect health assessments if the kit is used for patient monitoring.
Patients using the 6PLUS1 Multilevel Saliva Calibrator Set for cortisol and cortisone testing are affected. Those with the specific lots mentioned in the recall are at risk of inaccurate test results.
Check for the product name '6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva' with Order No. 73039. The affected lots are Lot 3219 (expires 08/01/2021) and Lot 1020 (expires 03/01/2022).
Identify the lot number on your calibrator set to see if it's Lot 3219 (expires 08/01/2021) or Lot 1020 (expires 03/01/2022).
The recall is because certain lots of the calibrator may not meet stability criteria, which could result in increased cortisol and cortisone test results for patients.
The official recall notice does not specify a remedy, so you should check with Chromsystems directly for further instructions.
Check the lot number on your calibrator set. Affected lots are Lot 3219 (expires 08/01/2021) and Lot 1020 (expires 03/01/2022).
We’ve drafted a message you can send Chromsystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0521-2021 — Chromsystems Chromsystems Hello, I own a Chromsystems that is covered by recall Z-0521-2021 from Chromsystems. 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.
