Recall Z-1124-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corporation
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number :20767107322 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to measure lipo
| Date | Dec 14, 2018 |
| Status | Terminated |
| Reason | COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over |
| Root cause | Device Design |
| Action | Roche Diagnostics issued on 12/14/18 "Urgent Medical Device Correction (UMDC) via UPS Ground (receipt required) Consignee Instructions: Manually add the EWCs listed in the Urgent Medical Device Correction (UMDC) on your COBAS INTEGRA 400 plus and cobas c 111 analyzers. If customers run the test combinations requiring needle assignment (See Table on page 3 of UMDC TP-00508), run those in batch mode until the updated TAS has been loaded on the COBAS INTEGRA 400 Plus analyzer. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you |
| Quantity | 656 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |