FDA Device recall Z-0176-2015

UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i…

FDA Device
Class II
terminated
Published 2014-11-12

On 2014-11-12 the FDA classified a Class II recall of UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i… by Beckman Coulter, citing beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0176-2015
Classification	Class II
Status	terminated
Initiated	2014-10-06
Published	2014-11-12
Last updated	2026-09-13 11:53 UTC
Company	Beckman Coulter
Distribution	US

Product

UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

Reason

Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system.

Identifiers

code_info	Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 5… Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626 509797 509669 509765 509790 509798 509739 509736 509769 509287 504104 509063 509256 509511 503600 505722 502105 504597 503503 504557 505476 504095 504060 503183 505154 506131 509267 509524 500646 509532 501760 509369 509514 509177 800135 509313 504619 800074 504591, 508910, 508912, 508907 509373, 509304 506566 508920 505811 508914, 508917 509625 502796 508933, 508934 509291 509634, 509635 509530, 509588 509787, 509788, 509783 509433, 509437, 509662, 509663, 509660, 509659, 509658 509715 509657 508916, 508566, 509344, 509526, 509424, 509461, 509459, 509466, 509062, 509197, 509200, 509195, 509196, 509201, 509199, 509605, 509604, 509571, 509585, 509567, 509569, 509568, 50

code_info

Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 5…

Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626 509797 509669 509765 509790 509798 509739 509736 509769 509287 504104 509063 509256 509511 503600 505722 502105 504597 503503 504557 505476 504095 504060 503183 505154 506131 509267 509524 500646 509532 501760 509369 509514 509177 800135 509313 504619 800074 504591, 508910, 508912, 508907 509373, 509304 506566 508920 505811 508914, 508917 509625 502796 508933, 508934 509291 509634, 509635 509530, 509588 509787, 509788, 509783 509433, 509437, 509662, 509663, 509660, 509659, 509658 509715 509657 508916, 508566, 509344, 509526, 509424, 509461, 509459, 509466, 509062, 509197, 509200, 509195, 509196, 509201, 509199, 509605, 509604, 509571, 509585, 509567, 509569, 509568, 50

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0176-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.