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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86981

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 08, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Roche Diagnostics Operations, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0754-2021
Recall number
Z-0754-2021
Initiated
December 08, 2020
Classification
Class II
Status
Ongoing
Quantity
1050 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 1214-20 1214-20 1214-20 1215-01 1215-01 1215-01 1215-17 1215-17 1215-17 1215-18 1215-20 1215-20 1215-20 1215-20 1216-18 1216-18 1325-01 1325-02 1325-03 1325-13 1325-13 1325-13 1325-14 1325-14 1325-14 1325-14 1325-14 1325-15 1325-16 1326-01 1326-01 1326-01 1326-02 1326-02 1326-02 1326-03 1326-03 1326-03 1326-04 1326-13 1326-14 1326-15 1326-16 1326-17 1326-17 1326-17 1326-18 1326-19 1326-19 1326-19 1326-20 1332-01 1332-01 1332-02 1332-02 1332-03 1332-06 1332-13 1332-14 1332-15 1332-16 1343-10 1344-01 1344-02 1344-03 1344-04 1344-05 1344-05 1344-05 1344-05 1344-06 1344-07 1344-08 1344-09 1344-09 1344-09 1344-10 1344-10 1344-10 1345-01 1345-03 1345-04 1345-05 1345-05 1350-06 1350-06 1350-07 1350-08 1351-02 1353-01 1353-02 1353-03 1353-03 1353-04 1353-04 1360-02 1360-02 1360-02 1360-03 1360-03 1360-03 1360-04 1361-05 1361-06 1361-06 1361-06 1361-09 1361-09 1361-10 1361-10 1362-01 1362-02 1362-03 1362-04 1362-04 1362-04 1362-04 1362-04 1362-05 1362-05 1364-02 1364-03 1364-04 1364-05 1364-06 1364-07 1364-08 1364-08 1366-01 1366-01 1366-01 1366-02 1366-02 1366-02 1366-04 1366-05 1366-06 1366-07 1366-08 1372-01 1372-01 1372-02 1372-06 1475-08 1475-08 1475-09 1475-10 1475-10 1485-07 1485-08 1485-09 1487-06 1487-07 1487-07 1488-02 1488-07 1492-06 1492-06 1492-06 1492-06 1492-06 1492-07 1492-08 1492-08 1492-08 1492-08 1492-08 1497-01 1497-02 1497-03 1497-03 1497-04 1497-04 1497-05 1497-06 1497-07 1497-08 1497-08 1497-08 1497-08 1497-08 1497-08 1497-08 1498-01 14A1-10 14A2-05 14A2-05 14A2-06 14A2-07 14A2-07 14A2-08 14C2-03 14C4-06 14C6-01 14C6-02 14C6-02 14C6-03 14C9-06 14C9-09 14C9-10 14C9-10 14D1-09 14D1-10 14D2-01 14D2-02 14D2-03 14D3-07 14D3-08 14D4-02 14D4-09 14D4-10 14D5-01 14D5-02 14D5-10 14D6-01 14D6-02 14D6-03 15F3-04 15F3-04 15F3-05 15F3-05 15F3-06 15F3-07 15F3-07 15F3-08 15F3-08 15F3-09 15F3-09 15G6-09 15G6-09 15G6-10 15G6-10 15G7-01 15H4-01 15H4-01 15H4-02 15H4-02 15H4-03 15H4-05 15H4-06 15H4-06 15H4-08 15H4-08 15H4-09 15H4-10 15H5-01 15H5-02 15H5-04 15H5-05 15H5-06 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

Distribution pattern

US Nationwide distribution.

device · product 2 of 2

Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001

Z-0755-2021
Recall number
Z-0755-2021
Initiated
December 08, 2020
Classification
Class II
Status
Ongoing
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10

Distribution pattern

US Nationwide distribution.