Roche Diagnostics Operations, Inc. recalls Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the…
A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L.
Read the official notice →- Date
- 2021-11-24
- Country
- United States
- Brand
- Roche Diagnostics Operations
- Product
- Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601…
- Classification
- Class II
- Units
- US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Roche Diagnostics Operations recalls
- 2026-01-14
USRoche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and…
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
FDA · DeviceRoche Diagnostics Operations, Inc.US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI,…Official notice →- 2024-11-27
- US
Roche Diagnostics Operations, Inc. recalls cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total…
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
FDA · DeviceRoche Diagnostics Operations, Inc.US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,Official notice → - 2024-10-02
- US
Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination…
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
- 2023-11-29
- US
Roche Diagnostics Operations, Inc. recalls Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311,…
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
- 2023-01-18
- US
Roche Diagnostics Operations, Inc. recalls cobas infinity central lab, Material Number 07154003001
A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information…
FDA · DeviceRoche Diagnostics Operations, Inc.Domestic distribution nationwide. Foreign distribution pending.Official notice → - 2022-08-17
- US
Roche Diagnostics Operations, Inc. recalls cobas e801 Immunoassay Analyzer
Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo…
FDA · DeviceRoche Diagnostics Operations, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →
Other drugs & medical recalls in the United States
- 2021-12-01
- US
- US
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals recalls Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC: 71335-1767-09, barcode…
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
- US
- 2021-11-24
- US
Smith & Nephew, Inc. recalls Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
The labels on the packages of screws were switched.
FDA · DeviceSmith & Nephew, Inc.Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME,…Official notice → - US
TiSport, Llc recalls Permobil TiLite, Models: Aero Z, and ZRA
Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident.…
FDA · DeviceTiSport, LlcUS Nationwide Distribution: MD, PA, VA, IN, NY, MO, AR, NE, NJ, WA, NM, IL,…Official notice → - US
CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
XXX
FDA · DeviceCooperSurgical, Inc.US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE,…Official notice →