| Class 2 Device Recall cobas 6000 MODULAR Series System c501 | |
Date Initiated by Firm | July 18, 2017 |
Create Date | March 06, 2018 |
Recall Status1 |
Terminated 3 on July 13, 2018 |
Recall Number | Z-0909-2018 |
Recall Event ID |
79130 |
510(K)Number | K060373 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product | cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V |
Code Information |
Serial numbers: 0948-27 0933-27 1214-11 1297-08 0947-23 0932-23 1113-22 16U0-02 16Z4-02 1246-12 1255-08 14F9-15 14F9-16 14M9-15 14M9-16 0963-17 0949-12 0967-13 0953-28 1741-10 14A3-14 14D5-01 14D5-17 14K0-17 1163-13 1163-14 1146-13 1146-14 1166-18 1149-18 1146-15 1148-16 1113-25 1113-26 1157-01 1157-02 1113-13 1113-14 16Z6-02 0809-22 0888-22 0762-15 0770-07 0756-15 0770-14 0756-22 0825-28 0806-28 1175-11 1161-11 0809-29 0888-29 15K6-10 15U2-10 0626-07 0748-13 0749-10 0629-12 0747-01 14J2-18 1243-13 1247-09 14D7-16 14D7-18 14K3-16 14K3-18 14C0-06 14G5-18 14F9-18 14G3-19 14M9-18 14P2-19 14E2-01 14F0-12 14K9-01 14M1-12 0956-15 0941-30 1151-17 1151-18 1123-17 1123-18 0956-06 1147-03 1147-15 1147-16 1112-02 1113-21 0955-29 0941-14 14D8-04 14D8-05 14K5-04 14K5-05 14E4-09 14D8-01 14K5-01 1184-04 1184-05 1174-06 1174-07 0955-21 0955-27 0940-27 0941-12 0813-21 0813-29 0893-22 0893-30 0793-06 0793-07 0776-18 0831-09 0818-29 0793-10 0776-21 0793-09 0776-20 0753-13 0766-11 15G8-04 15P7-04 0772-18 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1385-19 13C2-05 0955-19 0940-25 1356-05 1378-17 14B7-06 14G2-13 0956-05 0956-14 0941-20 0941-29 1035-06 1035-07 1007-17 1007-18 1208-04 1208-12 1291-01 1291-09 1208-13 1296-13 1283-08 1291-10 16R2-14 16Y0-14 16R2-15 16Y0-15 16S2-03 14B5-11 14B5-12 14F8-11 14F8-12 16R9-06 16Y6-06 0752-06 0888-26 16X0-02 16X0-07 1616-02 1616-07 16R2-13 16Y0-13 1152-13 1152-14 1127-08 1127-09 0899-07 0880-07 1027-15 1025-18 1094-19 0783-19 0768-17 1215-17 1298-13 14D4-01 14F9-05 14M9-05 16S9-19 16S9-20 16Z3-19 16Z3-20 14G2-04 14C3-09 13C2-10 14F9-11 14M9-11 14G3-07 14P2-07 1157-20 0766-08 0753-10 0808-28 0887-26 1184-07 1174-09 15H9-08 15R9-08 0967-09 0953-24 16P6-20 16U0-20 16U5-01 16Z4-20 16Z6-01 1214-14 1215-09 1297-11 1298-05 15G8-20 15P7-20 15L8-13 15V5-13 15L8-05 15V5-05 1233-15 1235-18 1253-09 1253-10 1372-04 1372-05 15J4-07 15S3-07 0640-11 0766-18 0753-20 1183-10 1183-11 1173-08 1173-09 0955-23 0940-29 1025-19 1025-20 1094-20 1094-21 1367-16 1367-17 1393-09 1393-10 14A9-20 14F0-12 15K0-07 15K0-08 15S9-02 15S9-03 0818-01 0897-26 1741-03 1149-13 1250-10 1265-05 14D5-12 14D5-13 14K0-12 14K0-13 16V7-04 1606-04 0953-29 1250-08 1265-03 0947-21 0932-21 14D7-11 14D7-12 14K3-11 14K3-12 0813-22 0893-23 14A9-18 14F0-10 1743-13 1743-14 1231-09 1231-10 1248-17 1248-20 1260-13 1260-16 1152-12 1127-07 1241-04 1380-20 1390-07 13A6-05 13B3-02 0768-07 0754-29 0783-14 0768-12 0783-10 0768-08 0899-04 0880-04 1027-14 0777-10 0762-29 0809-01 0887-29 1269-01 14A9-07 14E8-09 0828-01 0813-11 0959-12 0945-17 0844-30 0829-30 1390-14 13B3-09 0899-08 0880-08 16R9-14 16R9-15 16Y6-14 16Y6-15 15H9-16 15R9-16 1032-18 1004-01 16U5-06 16Z6-06 1148-01 1296-07 1283-02 14F9-17 14M9-17 0830-05 0817-25 0953-20 0938-21 1741-02 0766-01 0753-03 0766-05 0753-07 16R8-09 16V8-02 1607-01 1607-02 1390-08 1371-12 1371-13 1390-09 13B3-03 13B3-04 0844-29 0829-29 16X3-15 1619-15 1155-14 1155-15 1132-13 1132-14 1396-19 1396-20 13C0-03 13C0-04 14E3-06 0793-13 0776-24 14G2-02 14G3-06 15G8-02 14P2-06 15P7-02 1252-01 1252-02 1269-06 1269-07 0930-23 0817-14 0896-29 1017-06 1087-04 0770-17 0756-25 1151-06 1122-15 0812-29 0892-04 0618-19 0619-03
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13B7-03 0635-02 0636-23 16X0-03 1616-03 15J4-12 15S3-12 1015-16 1085-17 1029-12 1099-09 1176-19 1162-15 1169-09 1296-12 1283-07 0752-07 0747-28 14F9-06 14M9-06 16S2-04 1215-08 1298-04 1243-10 1247-06 1249-17 1263-09 14B3-07 14F5-08 14G3-13 14P2-13 0826-22 0807-22 16X3-13 1619-13 15J4-11 15S3-11 0828-12 0828-18 0813-22 0813-28 0822-20 0803-20 0822-29 0803-29 1241-05 1381-05 13A6-10 14B3-12 14F5-13 0758-03 0749-13 0639-15 0640-06 0813-05 0892-10 15H9-15 15J4-09 15R9-15 15S3-09 1394-18 13B7-06 0813-03 0813-04 0892-08 0892-09 14E2-10 14K9-10 0623-04 1166-15 1149-15 0749-09 0746-30 16V7-19 1606-19 16U5-04 16Z6-04 16U5-05 16Z6-05 0773-06 0773-08 0758-23 0758-25 0768-10 0770-05 0756-13 0765-20 0753-02 0790-11 0802-15 0802-16 0881-15 0881-16 0766-02 0753-04 0777-07 0762-26 0830-10 0897-25 0948-22 0933-22 15P3-12 14G3-11 14P2-11 15G8-07 15G8-09 15P7-07 15P7-09 1607-06 16V8-07 1607-07 1298-10 1285-15 14G3-14 14P2-14 1386-19 1386-20 13B1-07 13B1-08 0638-10 0638-18 0899-15 0880-15 0783-09 0784-20 0768-07 0768-20 0614-14 0614-14 0751-18 0751-19 1285-12 0959-10 0959-11 0945-15 0945-16 0965-19 0950-27 16R2-07 16Y0-07 1029-15 1099-12 15J4-17 15S3-17 1166-12 1149-12 0957-26 0943-24 0963-14 0949-09 14A7-01 14E4-12 1163-16 1163-17 1146-16 1146-17 16R2-10 16Y0-10 16R2-09 16Y0-09 1147-17 1147-18 1150-08 1150-09 1121-19 1121-20 14C0-08 14C0-09 14G5-20 14G6-01 15H4-17 16S9-12 16Z3-11 16Z3-12 14D8-02 14K5-02 1146-06 1117-10 15G8-08 15P7-08 14G2-01 15G8-03 15P2-18 15P7-03 15W9-18 15G8-13 15P7-13 15K6-01 14G0-07 15K6-02 15U2-01 15U2-02 0813-01 0892-06 0637-04 0637-05 0638-05 0638-06 0804-18 0883-03 0831-10 0818-30 1156-20 1113-11 0752-09 0747-30 0642-05 0641-25 0749-11 0747-02 0749-13 0747-04 1250-12 1265-07 1390-13 13B3-08 0817-03 0817-04 0896-18 0896-19 1188-20 0958-07 0944-05 0953-12 0938-13 1183-08 1173-06 14A8-14 14A8-15 14B7-07 14B7-09 14G2-14 14G2-16 1246-19 1255-15 1390-12 13B3-07 1390-11 13B3-06 14A5-10 14D9-17 14D5-08 14K0-08 16R9-03 16Y6-03 0804-22 15P2-14 15W9-14 15W9-13 15P2-13 16R9-16 16Y6-16 16U0-04 16Z4-04 0826-25 0807-25 1155-10 1155-11 1132-09 1132-10 0813-30 0894-01 0813-10 0892-15 15P2-12 15W9-12 15P2-03 15W9-03 16R9-04 16Y6-04 16U0-15 16Z4-15 0802-12 0881-12 16X3-05 1619-05 16Z1-08 1632-08 0813-06 0892-11 15P2-04 15W9-04 15W9-02 15P2-02 0841-29 0826-29 1026-01 1094-22 1026-02 1094-23 1143-10 1115-04 1033-09 1032-17 1003-30 1030-06 1032-16 1030-13 1030-20 1035-04 1035-05 1007-15 1007-16 1143-14 1146-05 1115-08 1117-09 1243-12 1247-08 0639-07 0639-28 0973-03 0973-04 0957-01 0957-02 0972-18 0972-19 0956-26 0956-27 1163-11 1146-11 1242-07 1243-12 15L8-03 15V5-03 16V8-19 1607-19 14F3-03 14F3-04 14M4-03 14M4-04 1214-16 1297-13 0623-17 0627-01 1176-20 1182-15 1182-16 1162-16 1172-13 1172-14 1174-14 1174-15 1160-14 1160-15 1176-18 1162-14 1182-10 1172-08 1252-15 1270-10 14D7-13 14K3-13 0945-25 0930-25 0955-09 0940-15 0828-09 14A3-16 14A5-11 14D5-03 14D9-18 15J4-05 15S3-05 15G8-15 15G8-16 15P7-15 15P7-16 16V3-02 16V7-03 1603-02 1606-03 0817-08 0825-29 0806-29 0896-23 1232-15 1252-08 1252-09 1270-03 1270-04 1386-17 13B1-05 1356-08 1378-20 1253-16 1253-17 1372-11 1372-12 1359-06 1382-16 1251-16 14F9-03 14F9-04 14M9-03 14M9-04 0770-12 0756-20 16X3-04 1619-04 16S0-18 0836-01 0821-21 16U6-03 16U6-04 16Z7-03 16Z7-04 0837-02 0822-27 16V8-11 16V8-13 1607-11 1607-13 1155-17 1155-18 1132-16 1132-17 1147-19 1112-22 1147-20 1113-05 0957-27 0943-25 0959-13 0945-18 16Z1-20 1632-20 16X3-07 16X3-08 1619-07 1619-08 0748-01 16U5-10 16Z6-10 16Z6-17 16V2-01 1602-01 17Z4-01 1734-01 1734-02 1380-18 13A6-03 0630-13 0632-24 16V2-02 1602-02 1172-15 1172-16 1157-15 1157-16 13A1-04 13A1-05 13D1-04 13D1-05 0640-06 0640-17 1184-12 0945-29 0930-29 1159-14 0818-05 0897-30 1248-15 1248-16 1260-11 1260-12 0963-15 0949-10 1231-11 1253-01 1253-02 1371-06 1371-07 0956-10 0956-11 0941-25 0941-26 0751-14 0748-15 1245-16 1252-12 1015-19 1085-20 1015-18 1085-19 0955-22 0940-28 15H3-18 15J9-14 15S8-09 0825-24 16U5-15 16Z6-15 16V9-05 1608-05 14F9-07 14M9-07 1361-07 1384-13 1364-08 1389-12 1236-15 1236-16 1364-11 1364-12 1367-14 1389-15 1389-16 1393-07 1251-13 1251-14 1268-08 1268-09 14B3-11 14F5-12 1395-05 13B7-13 13A1-01 13D1-01 15K0-09 15S9-04 0617-09 1013-20 1014-01 1083-21 1083-22 0805-30 0884-15 1013-05 1015-17 1085-18 1176-17 1162-13 0751-10 0748-11 0808-18 0808-25 0887-16 0887-23 16S2-06 1743-10 1210-10 1292-11 16S1-02 16S2-08 1706-09 1741-09 1381-03 1381-04 13A6-08 13A6-09 0776-14 0762-13 0965-11 0950-19 1013-18 1083-19 0841-28 0945-24 0826-28 0930-24 0636-20 0637-01 1119-03 1298-11 1285-16 0637-06 0638-07 0621-05 0625-09 1358-18 1380-14 1376-15 13A2-15 0836-06 0953-09 0821-26 0937-30 1231-12 1246-13 1255-09 1249-18 1263-10 0956-03 0956-09 0941-18 0941-24 0758-09 0758-10 0749-19 0749-20 1143-13 1115-07 1143-12 1115-06 1394-16 1394-17 13B7-04 13B7-05 0783-08 14G3-16 14P2-16 15H9-06 15R9-06 14G3-09 14P2-09 15P7-01 15G8-01 15K6-03 15U2-03 1248-11 1248-12 1260-07 1260-08 0808-19 0809-02 0887-17 0887-30 1391-20 13A0-03 14A3-11 14A7-08 14D4-18 14E4-19 0836-08 0821-28 0831-03 0831-04 0818-23 0818-24 14E3-04 14E3-05 14F3-12 14F9-19 14M4-12 14M9-19 1032-12 1003-25 1367-15 1393-08 1163-19 1146-18 1146-19 1174-19 1160-19 16W1-10 1610-10 1253-08 1253-13 1372-03 1372-08 0958-10 0944-08 0957-28 0943-26 1031-01 1036-20 1035-08 1143-07 1007-19 1115-01 14E2-04 14E2-05 14K9-04 14K9-05 0955-10 0940-16 1251-10 1251-11 1268-05 1268-06 14B1-06 14B1-07 14F3-03 14F3-04 14B1-13 14B1-14 14F3-10 14F3-11 1166-16 1166-17 1149-16 1149-17 0802-11 0881-11 1145-18 1073-19 1145-19 1113-30 1619-02 0825-22 0806-22 1232-17 1250-11 1265-06 14A5-17 14E0-04 1394-11 1394-12 13B6-19 13B6-20 1169-10 1173-13 1158-09 14E2-02 14E2-03 14K9-02 14K9-03 1013-19 1083-20 0777-09 0808-24 0887-22 0777-28 0953-04 0937-25 1252-11 1270-06 14G3-12 0625-11 0628-26 14C1-08 14C1-09 14G9-04 14G9-05 0948-24 0933-24 1184-03 1174-05 0962-07 0962-22 0954-02 0954-03 0939-10 0939-11 0953-15 0953-17 0938-16 0938-18 1242-04 1243-09 0953-13 0938-14 0953-30 0939-08 1186-12 1183-16 1173-14 0844-23 0829-23 0825-17 0822-21 0803-21 0817-11 0896-26 0963-06 0949-01 0804-16 0883-01 1299-07 1222-16 1290-10 1179-08 0784-13 0769-23 1376-19 1380-19 13A2-19 13A6-04 14A3-17 14D5-04 13A0-20 13D0-20 14F3-10 14M4-10 15V0-03 15L4-03 1356-10 1379-02 0793-17 0793-12 0776-23 0804-23 0883-08 0816-29 0821-23 0802-04 0821-24 0802-05 14P2-12 0963-18 0963-19 0949-13 0949-14 1367-18 1393-11 0965-12 0950-20 1245-17 1252-13 0813-24 0893-25 1252-10 1270-05 16X3-01 1619-01 16S2-09 1708-12 1743-12 16X3-09 16X3-10 1619-09 1619-10 0809-23 0888-23 0965-13 0950-21 1157-19 1236-13 0770-18 0772-19 0756-26 0758-16 1386-18 13B1-06 1032-15 1003-28 1032-19 1004-02 1029-11 1099-08 1032-10 1003-23 1032-11 1003-24 14B7-12 14G2-19 16V2-16 1602-16 1252-20 1371-05 14A9-16 14F0-08 16P6-03 16U0-11 16U5-09 16Z4-11 16Z6-09 0768-04 0754-26 1183-07 1173-05 1188-05 1177-04 1381-07 13A6-12 1381-06 13A6-11 1184-10 1172-11 1188-06 1177-05 0753-17 0809-30 0888-30 15J4-04 15S3-04 15J9-16 15S8-11 0794-12 0777-22 0758-13 0758-12 0954-09 0939-17 15J4-08 15S3-08 0758-02 0749-12 0776-16 14D4-04 14F3-09 14M4-09 14D5-07 14K0-07 14E3-08 15H9-19 15R9-19 15J4-06 15S3-06 15J4-02 15S3-02 0784-06 0769-16 16U6-01 16U6-02 16Z7-01 16Z7-02 14E4-07 15J4-14 15S3-14 1214-09 1297-06 1221-14 1207-12 1245-18 1252-14 14B3-02 14D5-20 14K0-20 16V7-10 1606-10 0955-17 0940-23 0817-29 0897-24 16R2-16 16Y0-16 0639-02 0639-23 0954-07 0939-15 16U5-07 16U5-08 16Z6-07 16Z6-08 1242-05 1243-10 14F9-10 14M9-10 1183-14 1173-12 16S9-10 16Z3-10 14B5-09 14F8-09 15H9-14 15J4-10 15R9-14 15S3-10 15J9-07 15J9-10 15S8-02 15S8-05 15J9-06 15J9-11 15S8-01 15S8-06 16R2-11 16Y0-11 0747-20 0746-01 0637-18 0638-19 0804-24 0883-09 1164-13 1182-07 1172-05 1215-14 1298-10 14F3-14 14M4-14 0783-17 0768-15 0768-03 0754-25 0631-01 0633-12 15H9-07 15R9-07 14E4-03 15K6-12 15U2-12 0776-12 0762-11 0783-20 14G3-05 14P2-05 15K6-13 15K6-14 15U2-13 15U2-14 15H9-13 15J4-15 15R9-13 15S3-15 1175-14 1175-15 1161-14 1161-15 15J4-18 15S3-18 1215-18 1298-14 1032-13 1032-14 1003-26 1003-27 0817-01 0896-16 15P2-01 15W9-01 16U5-16 16Z6-16 14E2-09 14F0-01 14K9-09 14M1-01 0630-02 0632-13 15J4-03 15S3-03 15G8-14 15P7-14 1245-13 1245-14 1245-15 1252-09 1252-10 1252-11 1741-08 0813-28 0817-10 0893-29 0896-25 0964-06 1017-03 1017-10 1087-01 1087-08 15K6-06 15U2-06 1250-01 1250-02 1263-13 1263-14 1019-16 1088-29 1143-08 1115-02 0981-01 0965-18 0950-26 16U0-12 16U0-13 16Z4-12 16Z4-13 16S9-13 16U0-10 16Z3-13 16Z4-10 16S0-07 16W1-01 1610-01 1204-06 1378-07 1380-12 13C2-07 13C2-08 0958-08 0944-06 1247-04 1247-05 1390-05 13B2-20 14D5-14 14K0-14 14E2-12 14E2-13 14K9-12 14K9-13 16R2-02 16Y0-02 16R8-08 16V8-20 1607-20 16R8-07 16V7-18 1606-18 1243-08 1243-09 0958-03 0944-01 1248-14 1260-10 |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corporation 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact | Vince Wong 317-521-7259 |
Manufacturer Reason for Recall | A warning is being added to the cobas 6000 MODULAR Series System - c501 and the cobas 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance. |
FDA Determined Cause 2 | Device Design |
Action | Actions Taken by Roche Diagnostics: A warning will be added to the cobas 6000 analyzer series Operators Manual and the cobas 8000 modular analyzer series Operators Manual. Actions to be Taken by the Operator: Operators are advised not to overtighten the thumb screws when replacing the USM Cover 3 after maintenance. When removing the screws for maintenance, avoid touching the edge of the USM Cover 3. Enclosure: Fax back form 7727-00-0717
Actions Required: " Do not overtighten the thumb screws when replacing the USM Cover 3 after maintenance. When removing the screws for maintenance, avoid touching the edge of the USM Cover 3. " Complete the attached fax form and fax it to 1-888-276-5901. " File or post this Urgent Medical Device Correction (UMDC) in an appropriate location within your laboratory, for future reference. |
Quantity in Commerce | 3433 |
Distribution | Distributed in all 50 states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MN, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, and Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JJE
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