Siemens Acute Care CKMB TestPak Recalled for Barcode Scanning Issues
Siemens Healthcare Diagnostics is recalling 1,051 units of Acute Care CKMB 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, and the hazard involves a functional defect (barcode scanning) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity issue.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 1,051 units of the Acute Care CKMB TestPak, an in vitro diagnostic test used to measure the MB isoenzyme of creatine kinase in heparinized plasma. The recall is due to a defect where the barcode labels on the Stratus CS Cartridge may not scan properly on Stratus CS systems.
The affected products are identified by Catalog Number CCKMB and SMN 10445068. Specific lot numbers involved in this recall are 245138002, 245152002, 245215002, and 245262002. The products were distributed worldwide, including in the United States, Canada, Australia, and numerous countries in Europe, Asia, and the Middle East.
Healthcare facilities and consumers should stop using the affected TestPaks and contact Siemens Healthcare Diagnostics for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 1,051
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 (4)
- Lot Numbers: 245138002
- 245152002
- 245215002
- 245262002
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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