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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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,, ,
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Roche Diagnostics Operations, Inc.
Reason for Recall:
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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,, ,

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1792-2014

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