CentraLink¿ Data Management System Software Versions recall
CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system…
Why was CentraLink¿ Data Management System Software Versions 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product codes: 10485061, 10484212, 10485064, 10483439, 10471393, 10484552, 10814296, 10815474, 11220480, 10481936, 10481937, 10481938, 10482170, 10482936, 10483437, 10483438, 10483440, 10484211, 10484213, 10485060, 10485062, 10485063, 10703007, 10703008, 10711638, 10711639, 10711640, 10711641, 10711643, 10811596, 10811597, 10811598, 10811599, 10811601, 10811741, 10811742, 10811743, 10814298, 10814877, 10814880, 10814881, 10815694, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181, 10819760, 10819943, 11219840, 11219841.
- Product
- CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 3,893 units
- Distribution
- 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.
- Recall date
- February 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)