CLASS II Device recall · Reported 9 Dec 2020 · FDA Enforcement Report

6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva recalled

Chromsystems Instruments & Chemicals is recalling 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, distributed nationwide in the US. The recall was initiated on 29 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOrder No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)

Quantity recalled148 package units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0521-2021
FDA event ID: 86699
Recalling firm: Chromsystems Instruments & Chemicals, Grafelfing, N/A
Classification: Class II
Status: Completed
Recall initiated: 29 Oct 2020
FDA classified: 2 Dec 2020
Reported: 9 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Patient Monitors

Timeline

29 Oct 2020	Recall initiated by company
2 Dec 2020	Classified by FDA	+34 days
9 Dec 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the states of NC and NY.

Nationwide North Carolina New York

Questions about this recall

Why was it recalled?

Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

Which lots are affected?

Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)

Where was it sold?

US Nationwide distribution in the states of NC and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 86699

Reported	Class	Recall	Company	Reason	Where
9 Dec 2020	CLASS II	MassChrom Cortisol, Cortisone Saliva Control Level II recalled	Chromsystems Instruments & Chemicals	Potency & Assay	Nationwide
9 Dec 2020	CLASS II	MassChrom Cortisol, Cortisone Saliva Control Level I recalled	Chromsystems Instruments & Chemicals	Potency & Assay	Nationwide

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