Siemens Acute Care BHCG CalPak Recalled Due to Barcode Scanning Issues
Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Acute Care BHCG CalPak because the cartridge 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) that could impact device operation but does not present an immediate risk of serious injury or death.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Siemens Acute Care BHCG CalPak, an in vitro diagnostic product used for calibration of the Stratus CS Acute Care rM ~ h CG method. 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 Catalog Number CBHCG-C and SMN 10445061. The specific lot number involved is 625229002. The product was distributed worldwide, including in the United States and numerous international locations such as Canada, Australia, and various countries in Europe and Asia.
Users of the Stratus CS system should check their inventory for the affected lot number. If the product is found, it should be removed from use and returned to Siemens Healthcare Diagnostics Inc. according to their instructions.
The recalled product
- Product
- Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 196
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: 625229002
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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