CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report

MassChrom Amino Acid Analysis Plasma Control Level I recalled

Chromsystems Instruments & Chemicals is recalling MassChrom Amino Acid Analysis Plasma Control Level I, distributed nationwide in the US. The recall was initiated on 2 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOrder No. 0471, Lot No. 2019 (expiration 05/01/2022)

Quantity recalled362 vials

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-0537-2021
FDA event ID: 86719
Recalling firm: Chromsystems Instruments & Chemicals, Grafelfing, N/A
Classification: Class II
Status: Terminated
Recall initiated: 2 Nov 2020
FDA classified: 4 Dec 2020
Reported: 16 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Patient Monitors

Timeline

2 Nov 2020	Recall initiated by company
4 Dec 2020	Classified by FDA	+32 days
16 Dec 2020	Published in enforcement report	+12 days

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

Reason for recall

Products do not meet stability criteria and may impact results.

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

MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates.

Nationwide California New York

Questions about this recall

Is MassChrom Amino Acid Analysis Plasma Control Level I recalled?

Yes. Chromsystems Instruments & Chemicals recalled MassChrom Amino Acid Analysis Plasma Control Level I on 2 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0537-2021.

Why was it recalled?

Products do not meet stability criteria and may impact results.

Which lots are affected?

Order No. 0471, Lot No. 2019 (expiration 05/01/2022)

Where was it sold?

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

More recalls from Chromsystems Instruments & Chemicals

All 9

Reported	Class	Recall	Company	Reason	Where
13 Jul 2022Device	CLASS II	MassCheck Amino Acid, Acylcarnitines Dried Blood Spot recalled	Chromsystems Instruments & Chemicals	Other	CT, NY, OH
13 Jul 2022Device	CLASS II	MassCheck Amino Acid, Acylcarnitines Dried Blood Spot recalled	Chromsystems Instruments & Chemicals	Other	CT, NY, OH
16 Dec 2020Device	CLASS II	MassChrom Amino Acid Analysis Plasma Control Level II recalled	Chromsystems Instruments & Chemicals	Other	Nationwide
16 Dec 2020Device	CLASS II	MassChrom Amino Acid Analysis Plasma Control Level III recalled	Chromsystems Instruments & Chemicals	Other	Nationwide
16 Dec 2020Device	CLASS II	3PLUS1 Multilevel Plasma Calibrator Set recalled	Chromsystems Instruments & Chemicals	Potency & Assay	Nationwide

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