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U.S. Department of Health and Human Services

Class 2 Device Recall 6PLUS1 Multilevel Saliva Calibrator Set

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  Class 2 Device Recall 6PLUS1 Multilevel Saliva Calibrator Set see related information
Date Initiated by Firm October 29, 2020
Create Date December 02, 2020
Recall Status1 Completed
Recall Number Z-0521-2021
Recall Event ID 86699
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Code Information Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)
Recalling Firm/
Chromsystems Instruments & Chemicals GmbH
Am Haag 12
Grafelfing Germany
Manufacturer Reason
for Recall
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm sent consignees a recall notification letter dated 10/28/2020. Consignees are asked to stop using products and to destroy remaining stock of affected product in accordance with the consignees laboratory procedures. The recalling firm will replace affected stock with new lots. Consignees are asked to further disseminate recall information to any other customers that the product has been shipped to. A response form is included with the recall notification letter and customers are asked to complete the form and return to the recalling firm.
Quantity in Commerce 148 package units
Distribution US Nationwide distribution in the states of NC and NY.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.