Class 2 Device Recall MassChrom Amino Acid Analysis Plasma Control Level II

• Date Initiated by Firm: November 02, 2020
• Create Date: December 04, 2020
• Recall Status: Terminated on December 20, 2021
• Recall Number: Z-0538-2021
• Recall Event ID: 86719
• Product Classification: Multi-analyte controls, all kinds (assayed) - Product Code JJY
• Product: 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.
• Code Information: Order No. 0472, Lot No. 2019 (expiration 05/01/2022)
• Recalling Firm/ Manufacturer: Chromsystems Instruments & Chemicals GmbH; Am Haag 12; Grafelfing Germany
• Manufacturer Reason for Recall: XXX
• FDA Determined Cause: Under Investigation by firm
• Action: Consignees are informed of this issue by Field Safety Notice FSN 03-2020 on 11/02/2020, also addressing the measures that should be taken by the consignees: If the products listed above were already used for measurements, consignees shall check with the attending physician(s) whether it is necessary to review the results of asparagine, homocystine and methionine. Consignees shall stop using the reconstituted products listed above that are stored more than 6 weeks at < -18 ¿C for measurements of asparagine, homocystine and methionine. Consignees shall destroy the remaining stock of reconstituted calibrators and controls that are stored more than 6 weeks at < -18 ¿C and were intended to be used in measurements of asparagine, homocystine and methionine according to their valid laboratory regulations. Chromsystems will replace stocks. Calibrators and controls will now have a reduced in-use stability (after reconstitution) for asparagine, homocystine and methionine of 6 weeks at < -18 ¿C. For all other analytes, in-use stability is not changed. If consignees have forwarded any of the products listed above to another laboratory, consignees shall inform that laboratory of the content of this letter and forward a copy. Consignees shall document their measures on provided Response document (attachment Response) and return their response until 20.11.2020 to Chromsystems (contact details provided in the attachment Response). Consignees shall make sure that all users of the products mentioned above and other persons affected in their organization are informed about the FSN. If they have provided third parties with these products, they shall forward a copy of this information or inform the contact person of Chromsystems.
• Quantity in Commerce: 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 Africa, Taiwan, Turkey, and United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.