Skip to content

cobas 8000 analyzer series Operators Manual Roche cobas recallZ-1792-2014 · Roche Diagnostics Operations, Inc. · initiated May 21, 2014

Class II Terminated All recalls posted in June 2014

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

Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

FDA root cause category: Labeling design

What the company is doing

Roche sent an Urgent Medical Device Correction (UMDC) letter dated May 20, 2014 via UPS Grount (receipt required) to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Follow the instructions in the Precautions Regarding Handling the Aspiration Tube Filter section in this UMDC; 2. Discontinue performing ProCell/Clean Cell aspiration tube filter check as this maintenance item will be performed by your Roche FSR as a part of service maintenance; 3. If you have distributed the products listed within this UMDC to other sites or facilities, please provide them with a copy of the UMDC; and 4. Complete the faxback form enclosed with this UMDC and fax it to 1-888-410-6620. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

Recall details

Recall number
Z-1792-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 21, 2014
Posted by the FDA
Jun 14, 2014
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
149
Product code
JJE
FDA submissions
K060373
Distribution
US Nationwide Distribution

Product description

cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

1125-07,1017-06,1021-03,1021-05,1016-05,1017-01,1124-05,1124-06,1128-02,1132-03,1132-04,1131-08,1132-01,1132-02,1128-05,1128-06,2374-11,1132-05,1132-10,1137-02,1139-08,1139-10,1140-07,1140-10,1140-08,1146-01,1146-02,1146-03,1139-06,1139-07,1139-09,1142-09,1145-10,1138-10,1139-01,1127-08,1138-08,1146-05,1146-06,1147-04,1156-04,1140-01,1147-05,1149-01,1149-07,1149-08,1167-02,1156-06,1158-09,1156-05,1158-10,1139-02,1139-03,1139-04,1139-05,1160-01,1160-05,1171-07,1171-08,1171-09,1173-10,1156-01,1160-04,1156-07,1156-02,1156-09,1160-06,1171-10,1173-01,1169-06,1169-08,1169-09,1172-09,1182-08,1211-15,1211-14,1174-08,1160-08,1171-06,1174-06,1174-07,1211-13,1211-06,1183-04,1217-09,1225-11,1211-16,1211-17,1211-18,1224-10,1156-08,1156-10,1225-14,1331-13,1338-15,1338-16,1211-19,1211-04,1211-05,1211-20,1208-08,1208-09,1211-02,1211-03,1338-12,1338-13,1338-14,1208-05,1211-07,1211-08,1458-04,1331-10,1331-11,1331-12,1334-15,1335-13,1344-02,1344-03,1344-04,1344-05,1344-06,1357-07,1357-08,1357-09,1357-10,1357-19,1357-20,1334-12,1334-13,1334-14,1459-12,1459-13,1357-15,1357-16,1357-17,1357-18,1335-08,1335-09,1335-10,1335-11,1344-01,1344-07,1344-08,1461-01,1461-02,1344-09,1459-14,1459-10,1459-11,, ,

Other devices under the same FDA submission

11 devices cleared under K060373 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 68294).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page