Chromsystems Instruments & Chemicals GmbH Recall 90266
Description: MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Chromsystems Instruments & Chemicals GmbH Recall 90266 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1336-2022 |
Event ID | 90266 |
Event Description | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I |
Product Type | Devices |
Distribution | US: NY, OH, CT. |
Quantity | 1330 units |
Recall Reason | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. |
Device Classification | 20220713 |
Device Code Info | Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841 |
Center Classification Date | 20220706 |
Recall Initiation Date | 20220519 |
Recalling Firm | Chromsystems Instruments & Chemicals GmbH |
Initial Notification | |
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