Recall archive / FDA device enforcement
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II — FDA record Z-1337-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
- Reason
- Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
- Classification
- Class II
- Recalling firm
- Chromsystems Instruments & Chemicals GmbH
- Quantity
- 1457 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1337-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model: 0193; Lot Number: 2821; UDI/DI: 04250317502865 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: NY, OH, CT.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 13, 2022
- Recall initiation date
- May 19, 2022
- Center classification date
- Jul 6, 2022
- Termination date
- May 15, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.