MassCheck Amino Acid, Acylcarnitines Dried Blood Spot… recallZ-1337-2022 · Chromsystems Instruments & Chemicals GmbH · initiated May 19, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Chromsystems Instruments & Chemicals GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-1337-2022
- Status
- Terminated
- Initiated by the company
- May 19, 2022
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH
- Quantity
- 1457 units
- Product code
- JJY
- Distribution
- US: NY, OH, CT.
Product description
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Code information (models, lots, serial numbers)
Model: 0193; Lot Number: 2821; UDI/DI: 04250317502865
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dried Blood Control 0193Chromsystems Instruments + Chemicals GmbH · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90266).
- Z-1336-2022 · TerminatedMassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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