Class 2 Device Recall MicroScan WalkAway Instruments

• Date Initiated by Firm: September 04, 2019
• Create Date: April 07, 2021
• Recall Status: Terminated on January 11, 2023
• Recall Number: Z-1373-2021
• Recall Event ID: 87486
• 510(K)Number: K911400
• Product Classification: Instrument for auto reader & interpretation of overnight suscept. Systems - Product Code LRG
• Product: MicroScan WalkAway-96 plus Reconditioned Instrument
• Code Information: Catalog Number: B1018-396R UDI Code: 15099590684129 Serial Numbers: 3967245 3967417 3967493 3967544 3967634 3967734 3967914 3928224 3968442
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Jose Untalan; 916-374-3031
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: On 09/04/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter to its customers via electronic and/or first class postal mail informing them that an investigation revealed that some instruments were manufactured with shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure. Customers were also informed that when a reagent is not dispensed, there is the potential for any of the following to occur: -high probability misidentifications and reporting of erroneous results -panel reads are flagged with exception requiring investigation (e.g. repeat the panel) causing delayed results. -QC failure requiring investigation (e.g. repeat the panel) causing delayed results The reagent draw straw is shorter than the probe level sensor, thus customers will not be notified by LEDs that the reagent system needs attention. Customers are instructed to: 1) Perform daily maintenance and manually verify the reagent volume in the 30mL bottles. Make sure each 30mL reagent bottle has at least 1 1/4 inch (approximately 1/2 full) of reagent or replace or refill bottles if necessary. 2) If the customer experienced an increase of reagents not dispensing, misidentifications and/or QC failures with their instrument, then a retrospective review of patient results is at the discretion of the Laboratory Director. The Recalling Firm will contact customers to schedule an onsite visit. During the visit the Recalling Firm's representative will install the reagent bottle assembly with the correct reagent draw straw length. Customers are asked to share this information with their laboratory staff and retain the recall notification as part of their laboratory Quality System documentation. If the affected systems have been forwarded to another laboratory, please provide a copy of the recall notification to them. Customers are asked to respond within 10 days that they have received
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LRG and Original Applicant = BAXTER HEALTHCARE CORP.