Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported December 9, 2020
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.
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Chromsystems Instruments & Chemicals GmbH recalled 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - P… - a moderate-severity action.
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - P… was recalled by Chromsystems Instruments & Chemicals GmbH in December 9, 2020. Reason: Calibrator lots may not meet stability criteria and could result in increased results of patient samples for …. Check the official notice for the remedy. Verify recall #Z-0521-2021 with the FDA Devices before acting.
The recall
Chromsystems Instruments & Chemicals GmbH issued this moderate-severity FDA Devices recall-Calibrator lots may not meet stability criteria and could result in increased results of patient samples for ….
- Moderate
- severity level
- Class II
- classification
- December 9, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0521-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0521-2021) was formally reported on December 9, 2020, with the manufacturer initiating the action on October 29, 2020. It is classified under Moderate severity (Class II), with a current status of Completed. Chromsystems Instruments & Chemicals GmbH is listed as the recalling firm, operating out of Grafelfing, N/A. Federal records list the affected scope as 148 package units.
The documented reason for this recall is: Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of NC and NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
148 package units
Related Recalls
6
3 from same agency
Product description
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 for recall
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-0521-2021 |
| Date reported | December 9, 2020 |
| Date initiated | October 29, 2020 |
| Recalling firm | Chromsystems Instruments & Chemicals GmbH |
| Firm location | Grafelfing, N/A |
| Affected scope | 148 package units |
| Distribution | US Nationwide distribution in the states of NC and NY. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0521-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Chromsystems Instruments & Chemicals GmbH. Units affected: 148 package units.
Why was this product recalled? ▼
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2020. Severity: Moderate. Recall number: Z-0521-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of NC and NY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0521-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 9, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.