Recall Z-0100-2017
Roche Diagnostics Operations, Inc. · initiated July 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.
Codes / lots: Not applicable
Reason for recall
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
FDA-determined cause: Device Design
Action taken
On 7/15/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, an updated cleaning procedure, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this UMDC. On 10/5/2016, URGENT MEDICAL DEVICE CORRECTION UPDATE notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification updated the 7/15/16 notification to include additional affected systems and to provide updated cleaning instructions for all systems via the enclosed Operators Manual addendum.
Details
- Recall number
- Z-0100-2017
- Initiated
- July 15, 2016
- Terminated
- June 5, 2017
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 9014 in total
- Distribution
- US Nationwide Distribution
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0094-2017 Class II | Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0095-2017 Class II | cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0096-2017 Class II | cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use.…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0097-2017 Class II | cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0098-2017 Class II | Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0099-2017 Class II | URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0101-2017 Class II | cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0102-2017 Class II | cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0103-2017 Class II | VS II Aliquoter System calculator/data processing module, for clinical use Product…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0104-2017 Class II | RSD 800A Aliquoting System calculator/data processing module, for clinical use Product…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0105-2017 Class II | RSD 800 Sorting System calculator/data processing module, for clinical use Product…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0106-2017 Class II | cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0107-2017 Class II | cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0108-2017 Class II | cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0109-2017 Class II | cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |
| Z-0110-2017 Class II | cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512…Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers… | 07/15/2016Terminated |