Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

Class I - Dangerous

🏥 Medical Devices Recalled: December 8, 2020 Roche Diagnostics Operations Other Medical Devices Nationwide

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Serial No. 1017-01 1017-04 1019-09 1019-09 1019-09 1020-01 1022-05 1022-05 1029-09 1029-09 1030-08 1030-09 1030-09 1030-10 1034-09 1036-07 1036-07 1138-03 1138-03 1138-04 1140-09 1140-10 1142-01 1142-02 1142-02 1142-04 1142-04 1142-05 1142-06 1142-08 1142-08 1142-08 1142-09 1142-09 1142-09 1142-10 1143-01 1143-06 1143-09 1143-09 1143-10 1144-01 1146-02 1147-01 1147-03 1147-04 1147-07 1147-09 1149-01 1150-04 1150-05 1150-06 1150-06 1150-06 1150-06 1150-06 1161-05 1161-06 1161-08 1161-08 1161-08 1161-08 1161-08 1163-07 1163-07 1163-07 1163-07 1163-07 1163-10 1163-10 1164-01 1167-06 1167-06 1167-06 1167-07 1167-07 1167-08 1167-08 1167-09 1167-09 1167-10 1167-10 1168-02 1168-02 1168-02 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-04 1168-04 1171-01 1171-01 1171-01 1171-02 1171-05 1206-02 1206-03 1206-04 1206-05 1206-05 1206-06 1206-06 1206-06 1206-06 1206-07 1207-07 1207-08 1207-08 1207-08 1207-09 1207-09 1214-17 1214-18 1214-19 1214-19 1214-19 1214-19 1214-19 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20M0-06 20M0-06 20M0-06 20M0-06 20M0-07 20M0-08 20M0-09 20M0-10 20M1-01 20M5-09 20M5-10 20M6-01 20M6-02 20M6-09 20M6-10 20P1-09 20P1-10 20P2-01 20P2-02 20P2-03 20P2-05 20P2-06 20P2-07 20P2-08 20P3-03 20P3-04 20P7-02 20P7-03 20P7-04 20P7-05 20P7-06 20P7-07 20P7-08 20R1-06 20R1-07 20R1-08 20R1-09 20R2-09 20R7-03 20S1-03 20S1-04 20S1-05 20S3-06 20S3-06 20S3-06 20S3-06 20S3-07 20S3-08 20S3-09 20S7-02 20S7-03 20S7-04
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

Product Codes/Lot Numbers:

Serial No. 1017-01 1017-04 1019-09 1019-09 1019-09 1020-01 1022-05 1022-05 1029-09 1029-09 1030-08 1030-09 1030-09 1030-10 1034-09 1036-07 1036-07 1138-03 1138-03 1138-04 1140-09 1140-10 1142-01 1142-02 1142-02 1142-04 1142-04 1142-05 1142-06 1142-08 1142-08 1142-08 1142-09 1142-09 1142-09 1142-10 1143-01 1143-06 1143-09 1143-09 1143-10 1144-01 1146-02 1147-01 1147-03 1147-04 1147-07 1147-09 1149-01 1150-04 1150-05 1150-06 1150-06 1150-06 1150-06 1150-06 1161-05 1161-06 1161-08 1161-08 1161-08 1161-08 1161-08 1163-07 1163-07 1163-07 1163-07 1163-07 1163-10 1163-10 1164-01 1167-06 1167-06 1167-06 1167-07 1167-07 1167-08 1167-08 1167-09 1167-09 1167-10 1167-10 1168-02 1168-02 1168-02 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-03 1168-04 1168-04 1171-01 1171-01 1171-01 1171-02 1171-05 1206-02 1206-03 1206-04 1206-05 1206-05 1206-06 1206-06 1206-06 1206-06 1206-07 1207-07 1207-08 1207-08 1207-08 1207-09 1207-09 1214-17 1214-18 1214-19 1214-19 1214-19 1214-19 1214-19 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15H6-06 15K9-08 15K9-09 15L0-02 15L9-09 15M6-07 15M6-09 15M6-10 15M7-01 15M7-02 15M7-03 15M7-03 15M7-04 15M7-04 15M7-05 15M7-05 15M7-06 15M7-06 15M9-03 15M9-04 15M9-07 15P0-02 15P2-08 15P5-03 15P5-03 15P5-04 15P5-04 15P6-03 15P6-03 15P8-09 15P8-10 15P9-01 15P9-01 15P9-02 15P9-02 15P9-03 15P9-05 15P9-06 15P9-07 15P9-07 15P9-08 15R8-01 15R8-01 15R8-04 15R8-04 15R8-05 15R8-06 15R8-07 15R8-10 15R8-10 15R9-01 15R9-02 15R9-03 15R9-04 15R9-05 15R9-06 15S3-03 15S3-04 15S3-08 15S3-10 1638-09 1639-01 1639-02 1639-03 1639-06 1639-07 1639-08 1639-09 1639-10 1640-01 1645-03 1647-09 1647-10 1647-10 1648-01 1648-01 1648-02 1648-03 1648-04 1648-05 1648-06 1648-07 1655-06 1655-07 1656-01 1656-02 16S8-03 16S8-04 16S8-05 16S8-07 16S8-08 16S8-09 16S9-01 16S9-02 16S9-02 16S9-03 16S9-03 16S9-04 16S9-05 16S9-08 16S9-08 16U1-05 16U1-09 16U1-10 16U2-01 16U2-02 16U2-03 16U2-04 16U2-09 16U2-10 16U5-02 16U5-03 16U5-04 16U5-10 16U6-01 16U6-01 16U6-02 16U6-02 16U6-03 16U6-05 16U6-06 16U6-07 16V9-03 16W0-06 16W0-07 16W0-08 16W0-09 16W4-07 16X4-07 16X4-08 16X4-09 16X4-10 16X5-01 16X5-02 16X5-03 16X5-04 16X5-05 16X5-06 16X5-07 16X5-08 16X5-09 16Y3-04 16Y3-05 16Y3-06 16Y3-07 16Y3-09 16Y3-10 16Y4-01 16Y4-01 16Y4-02 16Y4-02 16Y4-03 16Y4-03 16Y5-09 16Y5-10 16Y6-01 16Y6-02 16Y6-04 16Y6-05 16Y6-06 16Y6-10 16Y8-04 16Y8-05 16Y8-09 16Y8-09 16Y8-10 16Y9-01 16Y9-07 16Z2-01 16Z2-02 16Z2-03 16Z2-05 16Z2-06 16Z2-07 16Z2-08 16Z2-09 16Z8-05 1775-09 1779-02 1779-02 1779-03 1779-04 1779-05 1779-06 1779-07 1779-08 1795-01 1795-02 1795-03 1795-04 1795-05 1795-06 1795-07 1795-08 1795-10 1796-01 17A8-07 17A8-08 17A9-02 17A9-02 17B5-02 17B5-03 17B5-05 17B5-05 17B5-06 17B5-09 17B6-02 17D4-05 17D5-01 17D5-02 17D5-04 17D5-04 17D5-04 17D5-05 17D5-05 17D6-03 17D6-03 17D6-04 17D6-05 17D6-06 17D6-07 17D6-08 17D6-09 17E1-05 17E1-06 17E1-08 17E4-04 17E4-04 17E4-05 17E4-06 17E4-07 17E4-08 17E4-09 17E4-10 17F6-09 17F6-09 17F6-10 17F7-01 17F7-02 17F7-03 17G1-05 17G1-07 17G3-05 17G3-06 17G3-07 17G3-09 17G3-09 17G5-08 17G5-09 17G5-10 17G6-01 17G6-02 17G6-03 17H0-10 17H1-01 1814-06 1814-07 1814-08 1815-02 1815-04 1820-10 1820-10 1821-01 1821-06 1822-05 1822-08 1822-10 1823-02 1823-03 1829-05 1834-07 1835-03 18H5-03 18H5-03 18H5-03 18H5-04 18H5-05 18H5-06 18H5-07 18H5-08 18J6-03 18J6-04 18J6-05 18J6-06 18J6-07 18J6-08 18K0-04 18K0-05 18K0-06 18K3-01 18K3-02 18K3-03 18L0-09 18L0-10 18L1-01 18L1-02 18L1-03 18L1-04 18L1-05 18L1-06 18L1-08 18L1-09 18L1-10 18L2-02 18L2-03 18L2-04 18L5-04 18L5-05 18L5-06 18L5-06 18L5-07 18L5-08 18L5-09 18L5-10 18L6-01 18L6-02 18L6-02 18L6-03 18L6-04 18L6-04 18L8-09 18L8-10 18L9-04 18M3-03 18M3-04 18M3-05 18M3-06 18M3-07 18M3-08 18M3-09 18M3-10 18M4-01 18M4-02 18M4-03 18M4-04 18M4-05 18M4-06 18M5-02 18M5-03 18M5-05 18M6-09 18M6-10 18M7-01 18M7-02 18M7-03 18M7-05 18M7-06 18M7-07 18M7-08 18M7-09 18M8-02 18M8-05 18M8-06 18M8-07 18M8-09 18M9-04 18M9-04 18M9-05 18P5-03 18P5-04 18P5-05 18P5-07 18P5-08 18P5-09 18P5-10 18P6-01 18P6-02 18P6-04 18P6-05 18P6-06 18P6-07 18P6-08 18P6-09 18P6-10 18P7-01 18P7-02 18P7-09 18P8-02 18P8-04 18P8-05 18P8-06 18P8-07 18P8-08 18P8-09 18P8-10 18P9-01 18P9-02 18P9-03 18P9-04 18R2-04 18R2-05 18R2-07 18R5-09 18R5-10 18R6-01 18R6-02 18R6-03 18R6-04 18S3-07 18S3-09 18S3-10 18S4-01 18S4-02 18S4-03 18S4-04 18U8-05 18U8-06 18U8-07 18U8-08 18U8-09 18U8-10 18U9-02 18U9-03 18U9-04 18U9-05 18U9-06 18U9-08 18U9-09 18U9-10 18V0-06 18V0-07 18V0-08 18V0-09 18V0-10 18V1-01 18V1-02 18V1-03 18V1-04 18V1-06 18V3-02 18V3-03 18V3-04 18W1-07 18W1-08 18W1-09 18W1-10 18W2-01 18W2-05 18W2-06 18W2-07 18W3-05 18W3-06 18W3-07 18W3-08 18W3-09 18W3-10 18W7-01 18W7-02 18W7-04 18W7-05 18W7-06 18X0-06 18X0-07 18X1-03 18X1-04 18X7-04 18X7-05 18X7-06 18X7-07 18X7-08 18X7-09 18X7-10 18X8-01 18X8-02 18X8-03 18X8-04 18X8-05 18X8-06 18Y5-08 18Y5-09 19A3-09 19A3-10 19A4-01 19A4-02 19A4-03 19A4-04 19B2-05 19B2-08 19B2-09 19B9-07 19B9-08 19B9-09 19B9-10 19C0-01 19C0-02 19C0-03 19C0-04 19C0-05 19C0-06 19C0-07 19C0-08 19C0-09 19C6-01 19C6-02 19C6-03 19C6-03 19C6-04 19C6-05 19C6-06 19C6-07 19D1-02 19D1-03 19D5-03 19D5-04 19D5-05 19D5-06 19D5-07 19D5-08 19D5-09 19D5-10 19D6-01 19D6-02 19D6-03 19D6-04 19D6-05 19D6-06 19D6-07 19D6-08 19E1-01 19E1-02 19E1-03 19E1-04 19E1-05 19E1-06 19E1-07 19E1-08 19E6-01 19E6-02 19E6-03 19E6-04 19E6-05 19E6-06 19E6-07 19E6-08 19E6-08 19E6-09 19E6-10 19E7-01 19E7-02 19E7-03 19E7-04 19E7-05 19E7-06 19F0-10 19F1-02 19F1-03 19F1-04 19F1-05 19F1-07 19F1-08 19F5-09 19F5-10 19F6-01 19F6-02 19F6-03 19F6-04 19F6-09 19F6-10 19F7-01 19F7-02 19F7-03 19F7-04 19G1-05 19G1-07 19G1-09 19G1-10 19G2-01 19G2-02 19G2-03 19J0-09 19J0-10 20J1-02 20J1-03 20J1-04 20J5-02 20J5-03 20J5-04 20J5-05 20J9-07 20J9-08 20J9-09 20J9-10 20K0-01 20K0-02 20K0-04 20K2-10 20K3-01 20K3-02 20K3-03 20K3-04 20K3-05 20K3-06 20K3-07 20K3-08 20K3-09 20K3-10 20K4-01 20K4-02 20K4-03 20K4-04 20K4-05 20K4-06 20K4-07 20K4-08 20K4-09 20K5-01 20K5-02 20K5-03 20K5-04 20K9-06 20K9-07 20K9-08 20K9-09 20K9-10 20L0-02 20L0-03 20L4-06 20L4-07 20L4-08 20L4-09 20L5-01 20L5-02 20L5-05 20M0-04 20M0-05 20M0-06 20M0-06 20M0-06 20M0-06 20M0-07 20M0-08 20M0-09 20M0-10 20M1-01 20M5-09 20M5-10 20M6-01 20M6-02 20M6-09 20M6-10 20P1-09 20P1-10 20P2-01 20P2-02 20P2-03 20P2-05 20P2-06 20P2-07 20P2-08 20P3-03 20P3-04 20P7-02 20P7-03 20P7-04 20P7-05 20P7-06 20P7-07 20P7-08 20R1-06 20R1-07 20R1-08 20R1-09 20R2-09 20R7-03 20S1-03 20S1-04 20S1-05 20S3-06 20S3-06 20S3-06 20S3-06 20S3-07 20S3-08 20S3-09 20S7-02 20S7-03 20S7-04

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0754-2021

Related Recalls

cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL

Roche Diagnostics Operations

Class I - Dangerous

Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.

Jan 20, 2026 Other Medical Devices Nationwide View Details →

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

Roche Diagnostics Operations

Class I - Dangerous

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

Oct 17, 2024 Diagnostic Equipment View Details →

Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190

Roche Diagnostics Operations

Class I - Dangerous

Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.

Aug 15, 2024 Diagnostic Equipment Nationwide View Details →