Z-1337-2022Class II

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

Name: Z-1337-2022 MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Creator: Chromsystems Instruments & Chemicals GmbH
Published: 2022-05-19
License: https://open.fda.gov/license/

Chromsystems Instruments & Chemicals GmbH / initiated 2022-05-19 / Terminated / root cause: labeling and UDI

FDA source

Chromsystems Instruments & Chemicals GmbH began a recall of MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II on 2022-05-19. FDA classified it as Class II and gives the reason as "Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1337-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-19
Posted: 2022-07-06
Terminated: 2024-05-15
Recalling firm: Chromsystems Instruments & Chemicals GmbH
Product: MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Root cause tag: labeling and UDI
FDA root 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: 1457 units
Distribution: US: NY, OH, CT.
Product codes and lots: Model: 0193; Lot Number: 2821; UDI/DI: 04250317502865

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1337-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1336-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-13	2022-07-06
Z-1337-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-13	2022-07-06

Product code JJY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)