Medical Laboratory Control Material Recalled for Insufficient Glycine Concentration
Chromsystems is recalling MassCheck Amino Acid Acylcarnitines dried blood spot control material due to too-low glycine concentration in batch 2821. The defect was found in units distributed to New York, Ohio, and Connecticut.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II control material with out-of-spec glycine concentration poses potential risk of harm through inaccurate laboratory test calibration affecting medical testing. No reported illnesses or injuries have been documented.
Plain-English summary
Chromsystems Instruments & Chemicals GmbH is recalling MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I due to a concentration defect in batch 2821. The control material was found to contain glycine at a concentration below specifications.
This control material is used in clinical laboratories to calibrate and verify the accuracy of amino acid and acylcarnitine testing. When control materials do not meet specifications, they may not accurately calibrate the testing instruments, potentially leading to inaccurate patient test results.
The affected units were distributed to laboratories in New York, Ohio, and Connecticut. The recall includes 1,330 units identified by Model 0192, Lot Number 2821, and UDI/DI 04250317502841.
The recalled product
- Product
- MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
- Hazard
- concentration-error
- test-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model: 0192
- Lot Number: 2821
- UDI/DI: 04250317502841
Distribution
Distributed in 3 states:
- CT
- NY
- OH
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