Siemens Acute Care CKMB DilPak Recalled for Barcode Scanning Issues
Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak 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, and the hazard involves a functional defect (barcode scanning) rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for minor labeling or functional errors.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak, an in vitro diagnostic product used with the Acute Care CKMB TestPak. 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 product is identified by Catalog Number CCKMB-D and SMN 10445070. The specific lot number involved is 845173002. The product was distributed worldwide, including in the United States and numerous international locations such as Canada, Australia, and various European and Asian countries.
This recall is classified as Class II by the FDA. Consumers and healthcare facilities should stop using the affected product and contact Siemens Healthcare Diagnostics Inc. for further instructions or a replacement.
The recalled product
- Product
- Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 146
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 (1)
- Lot Numbers: 845173002
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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