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Roche Diagnostics Corporation

15 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage recall (Z-1927-2019)Roche Diagnostics Corporation2019-07-03
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage recall (Z-1928-2019)Roche Diagnostics Corporation2019-07-03
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795 recall (Z-1145-2019)Roche Diagnostics Corporation2019-04-13
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19* recall (Z-1146-2019)Roche Diagnostics Corporation2019-04-13
Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Prod recall (Z-1147-2019)Roche Diagnostics Corporation2019-04-13
CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Numbe recall (Z-0360-2019)Roche Diagnostics Corporation2018-11-02
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Di recall (Z-1610-2018)Roche Diagnostics Corporation2018-05-03
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche D recall (Z-1611-2018)Roche Diagnostics Corporation2018-05-03
cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche D recall (Z-1612-2018)Roche Diagnostics Corporation2018-05-03
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche D recall (Z-1613-2018)Roche Diagnostics Corporation2018-05-03
Brand Name: cobas c 6000 MODULAR Series System e 601 cobas c 8000 MODULAR Series System - recall (Z-0378-2018)Roche Diagnostics Corporation2018-01-16
Elecsys PreciControl Varia 3 recall (Z-2173-2017)Roche Diagnostics Corporation2017-05-31
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx recall (Z-1763-2017)Roche Diagnostics Corporation2017-03-23
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx recall (Z-1764-2017)Roche Diagnostics Corporation2017-03-23
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping recall (Z-1090-2017)Roche Diagnostics Corporation2017-01-24

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Every clearance here is in the API, with alerts when new ones post.