FDA Device recall Z-0521-2021
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patien…
- FDA Device
- Class II
- completed
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patien… by Chromsystems Instruments And Chemicals, citing calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0521-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-10-29 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Chromsystems Instruments And Chemicals |
| Distribution | US |
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.
Reason
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Identifiers
| code_info | Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0521-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.