Z-0521-2021Class II

6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 -

Name: Z-0521-2021 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 -
Creator: Chromsystems Instruments & Chemicals GmbH
Published: 2020-10-29
License: https://open.fda.gov/license/

Chromsystems Instruments & Chemicals GmbH / initiated 2020-10-29 / Completed / root cause: manufacturing process

FDA source

Chromsystems Instruments & Chemicals GmbH began a recall of 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... on 2020-10-29. FDA classified it as Class II and gives the reason as "Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0521-2021
Classification: Class II
Status: Completed
Initiated: 2020-10-29
Posted: 2020-12-02
Recalling firm: Chromsystems Instruments & Chemicals GmbH
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.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0521-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0521-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-09	2020-12-02
Z-0522-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-09	2020-12-02
Z-0523-2021	Class II	Completed	Voluntary: Firm initiated	2020-12-09	2020-12-02

Product code JIX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)