OneDraw A1C Test System
Drawbridge Health, Inc. · Model FD001 · UDI-DI 00863030000408
Description
The OneDraw™ A1C Test System is a single-use, sterile, capillary blood specimen collection, stabilization, and transportation system. The device incorporates lancets to make two small incisions in the skin and a vacuum to draw blood at the surface of the skin and through channels to deposit the blood onto collection and stabilization matrices. The collection kit is designed to facilitate in vitro laboratory testing of blood samples for clinical chemistry assays. OneDraw™ includes a collection device, transport sleeve, accessories, and instructions needed to collect, package, and mail the sample collection cartridge to the certified clinical laboratory for HbA1c testing.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2024-09-18 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. | The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analy |
| 2024-06-17 | Abbott Diagnostics Technologies AS | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could |
| 2024-02-07 | Siemens Healthcare Diagnostics, Inc. | The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that e |
| 2022-02-09 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2020-06-30 | Siemens Healthcare Diagnostics, Inc. | If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantag |
| 2020-05-04 | Siemens Healthcare Diagnostics, Inc. | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. |
| 2020-05-04 | Siemens Healthcare Diagnostics, Inc. | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. |
| 2018-10-05 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 pea |
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