Laboratory Control Material Recalled for Insufficient Glycine Concentration
Chromsystems has recalled MassCheck Amino Acid, Acylcarnitines dried blood controls (batch 2821) for insufficient glycine concentration. This may affect laboratory test accuracy.
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: This is an FDA Class II recall of a laboratory control material. Although no illnesses or injuries have been reported, the insufficient glycine concentration in the controls constitutes a risk-of-harm product that could affect diagnostic test accuracy.
Plain-English summary
Chromsystems Instruments & Chemicals GmbH is recalling MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II due to a detected defect in batch 2821. The recall affects 1,457 units distributed in New York, Ohio, and Connecticut.
The company identified too low a concentration of glycine in the dried blood controls of the affected batch (Model 0193, UDI/DI: 04250317502865).
Facilities using this control material should discontinue use of batch 2821 and contact Chromsystems Instruments & Chemicals for replacement product.
The recalled product
- Product
- MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
- Affected units
- 1,457
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: 0193
- Lot Number: 2821
- UDI/DI: 04250317502865
Distribution
Part of a larger recall action
This product is one of 2 recalled by Chromsystems Instruments & Chemicals GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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