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Chromsystems Instruments & Chemicals GmbH Recall 90266

Description: MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Chromsystems Instruments & Chemicals GmbH Recall 90266 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1336-2022
Event ID90266
Event DescriptionMassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Product TypeDevices
DistributionUS: NY, OH, CT.
Quantity1330 units
Recall ReasonToo low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Device Classification20220713
Device Code InfoModel: 0192; Lot Number: 2821; UDI/DI: 04250317502841
Center Classification Date20220706
Recall Initiation Date20220519
Recalling FirmChromsystems Instruments & Chemicals GmbH
Initial Notification E-Mail
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