FDA Medical Device Recalls (openFDA)
Chromsystems Instruments & Chemicals GmbH: MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
- Recall number
- Z-1336-2022
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH
- Product
- MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
- Status
- Terminated
- Initiated
- 2022-05-19
- Posted
- not on file
- Terminated
- 2024-05-15
- Reason
- Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
- 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
- 1330 units
- Distribution
- US: NY, OH, CT.
- Lot, serial or model codes
- Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 3003951180
- Firm city
- Grafelfing
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28