Chromsystems Instruments & Chemicals GmbH: Medical Device Recall in 2022 - (Recall #: Z-1337-2022)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2022.
Data Source: FDA.
Product Description:
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Product Classification:
Class II
Date Initiated: May 19, 2022
Date Posted: July 13, 2022
Recall Number: Z-1337-2022
Event ID: 90266
Reason for Recall:
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Status: Terminated
Product Quantity: 1457 units
Code Information:
Model: 0193; Lot Number: 2821; UDI/DI: 04250317502865
Distribution Pattern:
US: NY, OH, CT.
Voluntary or Mandated:
Voluntary: Firm initiated