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COBAS INTEGRA 800 Analyzer with software 9864.C2 recallZ-0168-2014 · Roche Diagnostics Operations, Inc. · initiated Sep 16, 2013

Class II Terminated All recalls posted in November 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof

FDA root cause category: Software Design Change

What the company is doing

Roche sent an Urgent Medical Device Correction letter dated September 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Diagnostics recommends tracking all ISE counters and manually requesting the corresponding Service Actions listed in the notification be monitored until updated software becomes available during Q4 2013. If the affected product was moved to another site, the notification is to be forwarded. consignees were asked to complete the attached faxback form and fax it to 1-877-266-0997 and file the Urgent Medical Device Correction (UMDC) for future reference. Question should be directed to Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 For questions regarding thisr ecall call 317-576-3911.

Recall details

Recall number
Z-0168-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 16, 2013
Posted by the FDA
Nov 5, 2013
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
527 units
Product code
JJE
FDA submissions
K951595
Distribution
Nationwide Distribution and Puerto Rico

Product description

COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.

Code information (models, lots, serial numbers)

software version 9864.C2

Other devices under the same FDA submission

11 devices cleared under K951595 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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