Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Brand
Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany
Lot Codes / Batch Numbers
Model: 0192, Lot Number: 2821, UDI/DI: 04250317502841
Products Sold
Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841
Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany is recalling MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I due to Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, NY, OH
Page updated: Jan 10, 2026