Roche Diagnostics Corporation
FDA Regulatory Profile
Roche Diagnostics Corporation appears in FDA public data with 39 recalls — including 1 Class I (most serious) —, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1979-2019, Class II) was initiated on June 3, 2019. Its most recent 510(k) clearance was granted on March 16, 2015.
Summary
- Total Recalls
- 39 (1 Class I)
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1979-2019 | Class II | The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in | June 3, 2019 |
| Z-1927-2019 | Class III | cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retri | April 4, 2019 |
| Z-1928-2019 | Class III | cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retri | April 4, 2019 |
| Z-1194-2019 | Class II | Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of | March 18, 2019 |
| Z-1249-2019 | Class II | cobas e 801 immunoassay analyzer | March 15, 2019 |
| Z-1368-2019 | Class II | Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processin | February 4, 2019 |
| Z-1146-2019 | Class II | Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 031 | December 17, 2018 |
| Z-1145-2019 | Class II | Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 | December 17, 2018 |
| Z-0784-2019 | Class II | Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM | December 17, 2018 |
| Z-1147-2019 | Class II | Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usa | December 17, 2018 |
| Z-1124-2019 | Class II | COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 | December 14, 2018 |
| Z-1125-2019 | Class II | cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Cat | December 14, 2018 |
| Z-0301-2019 | Class II | Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS | September 24, 2018 |
| Z-0360-2019 | Class I | CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625 | September 13, 2018 |
| Z-2944-2018 | Class II | Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical | July 16, 2018 |
| Z-2389-2018 | Class II | Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: Th | April 27, 2018 |
| Z-2390-2018 | Class II | Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: Th | April 27, 2018 |
| Z-2136-2018 | Class II | cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, soft | April 3, 2018 |
| Z-1610-2018 | Class II | cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnost | February 22, 2018 |
| Z-1613-2018 | Class II | cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnost | February 22, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141929 | ACCU-CHEK CONNECT DIABETES MANAGEMENT APP | March 16, 2015 |
| K142089 | ACCU-CHEK AVIVA EXPERT SYSTEM | December 17, 2014 |
| K133862 | ACCU-CHEK AVIVA PLUS SYSTEM | April 29, 2014 |
| K112528 | ELECSYS T4 CALCHECK 5 | October 18, 2011 |
| K070172 | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | April 17, 2007 |
| K070174 | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY | April 16, 2007 |