Chromsystems Instruments & Chemicals GmbH: Medical Device Recall in 2020 - (Recall #: Z-0537-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 2, 2020

Date Posted: December 16, 2020

Recall Number: Z-0537-2021

Event ID: 86719

Reason for Recall:

Products do not meet stability criteria and may impact results.

Status: Terminated

Product Quantity: 362 vials

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated