—#178651

Product

iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis.

FDA product code: LKM — Counter, Urine Particle
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K022774
Affected lot / code info: UDI: 10837461001317, 10837461001355, 10837461001256,10837461001300; All Part Numbers

Why it was recalled

Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

An Urgent Medical Device Recall letter was sent during the week of 10/28/2019 to the affected customers via mail and e-mail. The notice stated the misidentification issue as follows: Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics)." The following actions were provided to reduce the potential for this issue until a software update is available: - Follow good laboratory practice (GLP) and ensure that a unique identification system is in place. - Ensure that specimens are labeled with a unique Specimen ID and manual orders utilize a unique Specimen ID. - Do not reuse barcode number that identify different specimens. If barcode numbers must be reused, ensure results have been released from the LIS and the instrument Work List has been cleared. - Clear all manual Orders immediately after results are released, even if barcodes are used for subsequent runs (see iQ200 or iChemVELOCITY IFU, Chaper 7, Manual Orders).

Recalling firm

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

Distribution

Distribution pattern: Worldwide distributions.

Timeline

Recall initiated: 2019-10-28
Terminated: 2026-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178651. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.