🔍 RecallPedia

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Class I - Dangerous
🏥 Medical Devices Recalled: October 3, 2022 Beckman Coulter Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    MicroScan autoSCAN-4 Instrument Catalog Number: B1018-280 UDI-DI Code: 15099590658625 Serial Numbers for new manufactured: 400495, 400496, 400497, 400498, 400499, 400500, 400503, 400504, 400506, 400507, 400508, 400509 400510, 400511, 400512, 400513, 400514, 400515, 400516, 400517, 400518, 400519, 400520, 400521 400522, 400523, 400524, 400528 Diffuser Plate component Part Number: P/N 5639-0001 Serial Numbers for previously install base: 6685, 6786, 6826, 7480, 8449, 9911, 10405, 10446, 10886, 11219, 11295, 11424, 11815, 11841, 20351, 20403, 300003, 300175, 400058, 400080, 400234, 400340, 400354, 400373, 400444
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Beckman Coulter, Inc.
Reason for Recall:
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Product Codes/Lot Numbers:

MicroScan autoSCAN-4 Instrument Catalog Number: B1018-280 UDI-DI Code: 15099590658625 Serial Numbers for new manufactured: 400495, 400496, 400497, 400498, 400499, 400500, 400503, 400504, 400506, 400507, 400508, 400509 400510, 400511, 400512, 400513, 400514, 400515, 400516, 400517, 400518, 400519, 400520, 400521 400522, 400523, 400524, 400528 Diffuser Plate component Part Number: P/N 5639-0001 Serial Numbers for previously install base: 6685, 6786, 6826, 7480, 8449, 9911, 10405, 10446, 10886, 11219, 11295, 11424, 11815, 11841, 20351, 20403, 300003, 300175, 400058, 400080, 400234, 400340, 400354, 400373, 400444

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0269-2023

Related Recalls

Access Total T4 Calibrator, Catalog No. 33805

Beckman Coulter

Class I - Dangerous

Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

Mar 16, 2026 Other Medical Devices Nationwide View Details →

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.

Beckman Coulter

Class I - Dangerous

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

Nov 10, 2025 Other Medical Devices Nationwide View Details →