Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Brand
Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany
Lot Codes / Batch Numbers
Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
Products Sold
Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany is recalling MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is use due to Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026