Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents

• 3 recalls, same reason

  • Ongoing Z-2978-2024 FDA Class II ·initiated 17 Jul 2024
  • Ongoing Z-2980-2024 FDA Class II ·initiated 17 Jul 2024
  • Ongoing Z-2979-2024 FDA Class II ·initiated 17 Jul 2024

  The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

• • Terminated Z-1741-2020 FDA Class II ·initiated 17 May 2019 ·on shared 510(k) K140496

  Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K140496 ↗

FDA Product Code

CDD

Device Class

Class II

Regulation

21 CFR Part 862.1810

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Access Testosterone

  Class B

  CE/IVDR

• Access IL-6

  Class C

  CE/IVDR

• Access Ultrasensitive hGH

  Class B

  CE/IVDR

• Access Thyroglobulin

  Class C

  CE/IVDR

• Access HBs Ag

  IVD Annex II List A

  CE/IVDD

• Access Ultrasensitive Insulin

  Class C

  CE/IVDR

See all devices from Beckman Coulter, Inc. →

• What clinical chemistry assays are included in this Access Immunoassay System kit, and how are they used?

  This kit includes four radioassay-based tests: the Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, and Access HYPERsensitive hTSH Assay. They measure vitamin B12, ferritin, folate, and thyroid-stimulating hormone (TSH) levels in human serum and plasma (heparinized), respectively, using paramagnetic particle chemiluminescent technology. These assays support clinical chemistry diagnostics by quantifying these analytes to aid in diagnosing deficiencies, storage disorders, or thyroid dysfunction.

• Are the reagents single-use, and if so, why is this important for clinical workflows?

  Yes, the Access Immunoassay System reagents are supplied as sterile, single-use items. This design ensures each test is performed with fresh reagents, reducing the risk of contamination or degradation from repeated exposure to environmental factors. Single-use also streamlines workflows by eliminating the need for cleaning or reprocessing, which is particularly valuable in high-volume clinical settings where consistency and efficiency are critical.

• How does the Power Express Sample Processing System Generic Connection Module integrate with the Access Immunoassay System, and what role does it play?

  The Power Express Sample Processing System Generic Connection Module is designed to facilitate automated sample processing within the Access Immunoassay System. It ensures seamless compatibility, allowing for efficient handling and preparation of samples before analysis. This integration helps standardize workflows, reduce manual errors, and improve throughput in laboratories using the system.

• What regulatory pathways have these assays undergone, and what does that mean for their use in clinical settings?

  The assays are authorized under both FDA 510(k) clearance (K140496) and comply with the In Vitro Diagnostic Regulation (IVDR). This means they have undergone rigorous review to demonstrate safety, performance, and equivalence to existing devices, ensuring they meet stringent regulatory standards for clinical use. Clinicians can rely on these assays as validated tools for accurate diagnostic testing in their workflows.

• How should these reagents be stored to maintain their integrity, and why is proper storage important?

  Storage and handling of these reagents must follow the manufacturer’s guidelines to preserve assay integrity. While the exact conditions aren’t specified here, proper storage typically involves protecting reagents from light, extreme temperatures, and contamination. This is critical because improper storage can degrade the reagents, leading to inaccurate test results or compromised performance, which could impact patient diagnosis or treatment decisions.