MicroScan WalkAway-96 plus Reconditioned Instrument
Reported: April 14, 2021 Initiated: September 4, 2019 #Z-1373-2021
Product Description
MicroScan WalkAway-96 plus Reconditioned Instrument
Reason for Recall
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 9 systems
- Distribution
- U.S.: CO, FL, IL, IN, KY, ME, MI, MS, PA, Puerto Rico, TN, TX, UT, VA and WA O.U.S.: India, Indonesia, Italy, Japan, Philippines, Poland, Russia, South Korea, Taiwan and Yemen.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
MicroScan WalkAway-96 plus Reconditioned Instrument. Recalled by Beckman Coulter Inc.. Units affected: 9 systems.
Why was this product recalled? ▼
Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1373-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11