Roche Diagnostics Corporation
Roche Diagnostics Corporation holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2015, with 39 FDA device recalls on record.
Top product codes for Roche Diagnostics Corporation
FDA recalls by Roche Diagnostics Corporation
10 most recent of 39- Z-1979-2019 — The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
- Z-1928-2019 — cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
- Z-1927-2019 — cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
- Z-1194-2019 — Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
- Z-1249-2019 — cobas e 801 immunoassay analyzer
- Z-1368-2019 — Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
- Z-0784-2019 — Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
- Z-1147-2019 — Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
- Z-1146-2019 — Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.
- Z-1145-2019 — Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Roche Diagnostics Corporation
- K141929 — ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
- K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM
- K133862 — ACCU-CHEK AVIVA PLUS SYSTEM
- K112528 — ELECSYS T4 CALCHECK 5
- K070172 — AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K070174 — AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
Data sourced from openFDA. This site is unofficial and independent of the FDA.