Recall Z-0542-2026— Cellavision AB

Name: FDA recall Z-0542-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-08

Class II · Ongoing

Class II FDA medical device recall by Cellavision AB, initiated 2025-10-08. It names one FDA 510(k) clearance: K092868. Product: REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.. Reason: Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results..

Recalling firm: Cellavision AB
Classification: Class II
Status: Ongoing
Initiated: 2025-10-08
Firm location: Lund, Sweden

510(k) clearances named in this recall

1 on FDA's record

K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127CellaVision AB·cleared 2009-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.

Reason for recall

Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.