Siemens Acute Care CCRP TestPak Recalled for Barcode Scanning Issues
Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak 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 is a functional defect (barcode scanning) rather than a direct health risk or injury, fitting the criteria for a moderate severity issue.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak, an in vitro diagnostic product used for calibration of the CCRP method on the Stratus CS analyzer. The recall is due to a defect where the cartridge barcode labels may not scan on the Stratus CS systems.
The affected product is identified by Lot Number 425229002, Catalog Number CCCRP, and SMN 10445066. The units were distributed worldwide, including in the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East.
Healthcare facilities and users should stop using the affected TestPaks and contact Siemens Healthcare Diagnostics Inc for further instructions or replacement.
The recalled product
- Product
- Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 78
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 Number: 425229002
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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