Siemens Acute Care MYO TestPak Barcode Labels May Not Scan
Siemens Healthcare Diagnostics Inc is recalling 608 units of Acute Care MYO TestPaks because barcode labels may not scan on Stratus CS systems.
What this means for you
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. The hazard involves a functional defect (barcode scanning) that may impede device operation, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 608 units of the Acute Care MYO TestPak, an in vitro diagnostic test used for the quantitative measurement of myoglobin in heparinized plasma. The recall affects specific lot numbers: 515146002, 515201002, and 515285002.
The reason for the recall is that the Stratus CS Cartridge Barcode labels may not scan on Stratus CS systems. This issue could prevent the proper identification or processing of the test cartridges.
The affected products were distributed worldwide, including in the United States and numerous international locations such as Canada, Australia, and various European and Asian countries. Healthcare facilities and laboratories that have these specific lot numbers should stop using the affected TestPaks and contact Siemens Healthcare Diagnostics Inc for further instructions.
The recalled product
- Product
- Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 608
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: 515146002
- 515201002
- 515285002
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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