Siemens Acute Care DDMR TestPak Barcode Scanning Recall
Siemens Healthcare Diagnostics is recalling Acute Care DDMR TestPaks because barcode labels may not scan on Stratus CS systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional defect (barcode scanning failure) rather than a direct safety risk like contamination or structural failure, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 2,647 units of the Siemens Acute Care DDMR TestPak (Catalog Number: CDDMRE, SMN: 10701511). The recall is due to a defect where the barcode labels on the Stratus CS Cartridge may not scan on Stratus CS systems.
The affected units were distributed worldwide, including in the United States and 30 other countries. The specific lot numbers involved are 405131002, 405173002, 405187002, 405208002, 405229002, 405278002, and 405292002.
Healthcare facilities should stop using the affected TestPaks and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 2,647
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 (6)
- Lot Numbers: 405131002
- 405173002
- 405187002
- 405208002
- 405229002 405278002
- 405292002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Siemens Healthcare Diagnostics Inc 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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