—#186208

Product

MicroScan WalkAway-96 plus Instrument

FDA product code: LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K911400
Affected lot / code info: Catalog Number: B1018-284 UDI Code: 15099590658687 Serial Numbers: 39610001 39610002 39610003 39610004 39610005 39610006 39610007 39610008 39610009 39610010 39610011 39610012

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-09-04
Terminated: 2023-01-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186208. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.