Recall record at a glance
| Official record | Z-1204-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Feb 22, 2017 |
| Recall initiation date | Nov 29, 2016 |
| Quantity | 3,893 units |
| Location | Tarrytown, NY, United States |
Official product description
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 all connected instruments so that an operator can review and edit patient and quality control results from a single location. Siemens Healthcare Diagnostics has determined that there is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type.
Why the product was recalled
There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.
Distribution information
Worldwide Distribution - USA (nationwide) 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; and to the country of Canada and others.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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