FDA Device recall Z-0516-2020
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows:…
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows:… by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0516-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-07 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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.
Identifiers
| code_info | Catalog Number 775222. Serial numbers: AS39017, AS40018, AT35013, AT35014, AT35015, AT35017, AT35018, AT40020, AT40021…Catalog Number 775222. Serial numbers: AS39017, AS40018, AT35013, AT35014, AT35015, AT35017, AT35018, AT40020, AT40021, AT40022, AT40024, AT40025, AT40027, AT40030, AT45031, AT45032, AT45034, AT45035, AT49037, AT49041, AT49044, AT49045, AT49046, AT49047, AT49048, AT49049, AT49050, AT49051, AT49055, AT49057, AT49058, AT49059, AT49060, AT49061, AT49062, AT49063, AT49064, AT49065, AU01004, AU01005, AU01007, AU01009, AU01010, AU01011, AU01012, AU01014, AU01015, AU01016, AU01017, AU01020, AU01021, AU01022, AU01023, AU01024, AU01025, AU01028, AU01029, AU01030, AU08041, AU08043, AU08044, AU08047, AU08048, AU08049, AU08050, AU11051, AU11053, AU11057, AU11058, AU11059, AU11061, AU11062, AU11063, AU11064, AU11066, AU11068, AU11072, AU13073, AU13075, AU13077, AU13079, AU14083, AU14084, AU14085, AU14086, AU14087, AU14088, AU14090, AU16104, AU16111, AU16112, AU19113, AU19115, AU19118, AU19119, AU19120, AU20123, AU20124, AU20125, AU20128, AU20129, AU20130, AU20131, AU21133, AU21136, AU21137, AU2114 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0516-2020%22
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