Recall Z-0516-2020— Beckman Coulter, Inc.

Name: FDA recall Z-0516-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-07

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2019-10-07, terminated 2021-04-27. It names one FDA 510(k) clearance: K140911. Product: UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.. Reason: When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Terminated: 2021-04-27
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K140911 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMBeckman Coulter, Inc.·cleared 2014-09-05

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

UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Reason for recall

When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.

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