Class 2 Device Recall MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

• Date Initiated by Firm: May 19, 2022
• Create Date: July 06, 2022
• Recall Status: Completed
• Recall Number: Z-1336-2022
• Recall Event ID: 90266
• Product Classification: Multi-analyte controls, all kinds (assayed) - Product Code JJY
• Product: MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
• Code Information: Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841
• Recalling Firm/ Manufacturer: Chromsystems Instruments & Chemicals GmbH; Am Haag 12; Grafelfing Germany
• For Additional Information Contact: regulatory@chromsystems.com; +49 8918930 200
• Manufacturer Reason for Recall: Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
• FDA Determined Cause: Labeling Change Control
• Action: The firm issued a recall notification on 05/19/2022 via email. The notification mentions if the consignee has used the affected product, check whether they have determined glycine, replace the old package insert with the updated package insert with release date 18.05.2022, forward a copy of the letter to another laboratory if the affected product was given to them, and submit the response form by 01.06.2022. If users determined glycine, they are asked to clarify with the attending physician or laboratory director, if necessary, whether a back-check of the values for glycine is required.
• Quantity in Commerce: 1330 units
• Distribution: US: NY, OH, CT.
• 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.