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.
Reported: December 16, 2020 Initiated: November 2, 2020 #Z-0537-2021
Product Description
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.
Reason for Recall
Products do not meet stability criteria and may impact results.
Details
- Recalling Firm
- Chromsystems Instruments & Chemicals GmbH
- Units Affected
- 362 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 Africa, Taiwan, Turkey, and United Arab Emirates.
- Location
- Grafelfing, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Chromsystems Instruments & Chemicals GmbH. Units affected: 362 vials.
Why was this product recalled? ▼
Products do not meet stability criteria and may impact results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0537-2021.
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