FDA Device recall Z-1077-2019
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line
- FDA Device
- Class II
- ongoing
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class II recall of The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line by Beckman Coulter, citing when racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1077-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-05 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Beckman Coulter |
| Distribution | AK, AL, CA, DC, FL, GA, ID, IL, IN, KY, LA, MA, MI, MN, MS, NC, ND, NJ, NY, OH, PA, TN, TX, WA, WI, WV |
Product
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
Reason
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
Identifiers
| code_info | Systems running software versions: 5.2, 5.3.0, 5.3.1. Serial #: 605042 605047 605048 605050 606363 606439 90161…Systems running software versions: 5.2, 5.3.0, 5.3.1. Serial #: 605042 605047 605048 605050 606363 606439 901612 901626 605300 605301 605516 900777 605636 606566 606567 606383 606744 606745 605996 606161 606169 606231 606500 606565 606155 606156 606302 606740 606743 604566 604622 604624 604627 604713 606646 606746 604912 604951 606128 606386 606324 605932 606755 603377 604309 605909 604410 605372 604178 604426 604796 604744 602700 603298 603660 603797 603897 605762 604608 606411 604345 602472 603059 603513 603837 601829 602930 603217 604703 605201 605216 606557 604207 604929 605768 605769 605978 602139 606572 602417 601931 606104 602469 604115 604947 604682 604733 601919 602088 606201 601852 604699 605302 603647 606090 602077 602601 605449 603250 605199 605736 604827 603609 605492 604628 602084 602310 605211 605633 606763 606770 602074 604307 606257 604046 602063 603338 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1077-2019%22
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