Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0539-2021 — MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - 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.

U.S. FDA — Device Enforcement · Germany · 2020-11-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0539-2021
Date of alert: 2020-11-02
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Chromsystems Instruments & Chemicals GmbH
Product category: device
Product type: Devices

Reported risk: XXX

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0539-2021 — MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - 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.

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