Siemens Acute Care BHCG TestPak Recalled for Barcode Scanning Issues
Siemens Healthcare Diagnostics is recalling 590 units of Acute Care BHCG 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 involves a functional defect (barcode scanning) rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 590 units of the Acute Care BHCG TestPak, an in vitro diagnostic product used for calibrating the Stratus CS Acute Care hCG method. The recall is due to a defect where the cartridge barcode labels may not scan on Stratus CS systems.
The affected product is identified by Catalog Number CBHCG and SMN 10445060. The specific lot numbers involved in this recall are 445146002, 445201002, and 445243002. The agency classifies this as a Class II recall.
The product was distributed worldwide, including in the United States, Canada, and numerous countries in Europe, Asia, Africa, and the Middle East. Users of the Stratus CS system should check their inventory for these specific lot numbers and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 590
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 (3)
- Lot Numbers: 445146002
- 445201002
- 445243002
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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