—#205056

Product

iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684

FDA product code: LKM — Counter, Urine Particle
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K022774
Affected lot / code info: a) 700-3320, UDI/DI 10837461001188; b) 700-3370, UDI/DI 10837461001324; c) 700-3345, UDI/DI 10837461001300; d) 700-3347, UDI/DI 10837461001317; e) C10683, UDI/DI 15099590697129 f) 700-3375, UDI/DI 10837461001355; g) 700-3325, UDI/DI 10837461001256; h) C10684, UDI/DI 15099590695484; All serial numbers

Why it was recalled

Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/19/2023 via first class mail and email. The notice explained the issue, its impact on test results, and requested the following actions be taken: - Continue to run a complete Quality Control (QC) rack [including Iris Cleanser, Iris Diluent, iQ Focus and iQ Controls] as directed per iQ200 Series Instructions for Use (IFU) (300-4320 CE or 300-4321 EE) and DxU 850m and 840m Iris IFU (C49320 AB) - If the QC passes: o Run patient samples as routine - If the QC fails: o Refer to the IFU, Chapter 10 Troubleshooting; iQ200 Series IFU or DxU 850m and 840m Iris IFU o If the failure persists, contact your Beckman Coulter Representative - If a "Sequential Flags" Alarm displays: Refer to the IFU, Chapter 10; Alarm #25; iQ200 Series IFU or DxU 850 and 840m Iris IFU o If the alarm persists, contact your Beckman Coulter Representative Additional weekly action if using DxU 850m/840m Microscopy Analyzers: Visually inspect the iQClear Rinse Waste Well jets weekly for rust o If the iQClear shows rust on the rinse jets, contact your Beckman Coulter Representative Consult with your laboratory management to determine whether a retrospective review of results is necessary. For questions regarding this notice, please contact Customer Support Center or your local representative; From our website: http://www.beckmancoulter.com By phone: call 800-526-7694 in the United States and Canada. o Outside the United States and Canada, contact your local Beckman Coulter representative.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 11800 Sw 147th Ave, Miami, Florida 33196-2500

Distribution

Distribution pattern: US and Australia, Brazil, Canada, China, France, Germany, Ghana, India, Israel, Italy, Lebanon, Lithuania, Mexico, Panama, Qatar, Romania, Saudi Arabia, Spain, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland,

Timeline

Recall initiated: 2023-12-19
Posted by FDA: 2024-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205056. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.