FDA Device recall Z-0484-2013
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ Taq…
- FDA Device
- Class II
- terminated
- Published 2012-12-19
On 2012-12-19 the FDA classified a Class II recall of Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ Taq… by Roche Molecular Systems, citing roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0484-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-16 |
| Published | 2012-12-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
Reason
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Identifiers
| code_info | Device-associated diagnostic software |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0484-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.