Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 16, 2020
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - 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.
XXX
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Chromsystems Instruments & Chemicals GmbH recalled MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: Th… - a moderate-severity action.
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: Th… was recalled by Chromsystems Instruments & Chemicals GmbH in December 16, 2020. Reason: XXX. Check the official notice for the remedy. Verify recall #Z-0538-2021 with the FDA Devices before acting.
The recall
Chromsystems Instruments & Chemicals GmbH issued this moderate-severity FDA Devices recall-XXX.
- Moderate
- severity level
- Class II
- classification
- December 16, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0538-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0538-2021) was formally reported on December 16, 2020, with the manufacturer initiating the action on November 2, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Chromsystems Instruments & Chemicals GmbH is listed as the recalling firm, operating out of Grafelfing, N/A. Federal records list the affected scope as 363 vials.
The documented reason for this recall is: XXX Distribution data in the federal record shows the product reached: 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, Swi…. 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 - 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 - 40,422 medical devices recalls on record
Where this recall sits in the database
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
363 vials
Related Recalls
6
0 from same agency
Product description
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - 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.
Reason for recall
XXX
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0538-2021 |
| Date reported | December 16, 2020 |
| Date initiated | November 2, 2020 |
| Recalling firm | Chromsystems Instruments & Chemicals GmbH |
| Firm location | Grafelfing, N/A |
| Affected scope | 363 vials |
| Distribution | 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 Afri… |
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-0538-2021) 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? ▼
MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - 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.. Recalled by Chromsystems Instruments & Chemicals GmbH. Units affected: 363 vials.
Why was this product recalled? ▼
XXX
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0538-2021.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0538-2021) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported December 16, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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.