Siemens CentraLink Software Recalled for Potential Sample Type Omission
Siemens is recalling CentraLink Data Management System software versions v13x, v14x, and v15x because the system may download orders to the ADVIA Automation System without specifying the sample type.
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 source describes a 'remote possibility' of a data management error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the CentraLink Data Management System Software, specifically versions v13x, v14x, and v15x. The CentraLink system is a network solution provider and multi-system data manager used to consolidate data from laboratory instruments and lab automation systems (LAS). It allows operators to review and edit patient and quality control results from a single location.
The recall is due to a remote possibility that the CentraLink software may download an order to the ADVIA Automation System without specifying the sample type. This issue can occur when an order is received from the Laboratory Information System (LIS) without a sample type, requiring the sample type to be set in CentraLink based on the test in the order.
The recall affects 3,893 units distributed worldwide, including nationwide distribution in the United States to the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, and WV, as well as to Canada and other countries. Affected product codes are listed in the source metadata. Users of this software should contact Siemens Healthcare Diagnostics for further instructions on corrective actions.
The recalled product
- Product
- CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,893
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 (20)
- Product codes: 10485061
- 10484212
- 10485064
- 10483439
- 10471393
- 10484552
- 10814296
- 10815474
- 11220480
- 10481936
- 10481937
- 10481938
- 10482170
- 10482936
- 10483437
- 10483438
- 10483440
- 10484211
- 10484213
- 10485060
Distribution
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