Beckman Coulter Inc. MicroScan WalkAway-40 plus Instrument Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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

Distribution

As reported by FDA

CO, FL, IL, IN, KY, ME, MI, MS, PA, TN, TX, UT, VA, WA, PR