Siemens Acute Care MYO DilPak Recall Due to Barcode Scanning Issues
Siemens Healthcare Diagnostics Inc is recalling 192 units of Acute Care MYO DilPak in vitro diagnostic products 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, but the hazard is a functional defect (barcode scanning) rather than a direct safety risk like contamination or injury, fitting the Moderate category for minor operational issues.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 192 units of the Acute Care MYO DilPak in vitro diagnostic product (Catalog Number: CMYO-D, SMN:10445081). 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 products are distributed worldwide, including in the United States, Canada, Australia, and various countries in Europe, Asia, and the Middle East. The specific lot numbers involved in this recall are 815131002 and 815222002.
Users of these products should check their inventory for the affected catalog and lot numbers. If the products are found, they should stop using them and contact Siemens Healthcare Diagnostics Inc for further instructions on how to return or dispose of the units.
The recalled product
- Product
- Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 192
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 (2)
- Lot Numbers: 815131002
- 815222002
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.
See all 11 products in this recall →Related recalls
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