Beckman Coulter, Inc.: Access 2 Immunoassay Analyzer, Catalog Number 81600N

Hazard

Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.

Details from the source

Reason for recall: Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results. Distribution: Worldwide - US Nationwide distribution. Quantity: 873 units Lot/code info: UDI-DI: 15099590265380; Serial Numbers: 574626 574627 574839 574840 574841 574842 574852 574853 574854 574378 573724 574432 574538 574907 574497 574303 574184 574218 574219 574305 574332 574333 574345 574346 574414 574451 574581 574582 574583 574584 574726 574727 574728 574729 574730 574731 574732 574733 574920 574922 574923 574955 574957 574958 574959 574984 574985 574986 574987 574811 574160 574161 574167 574168 574169 574171 574177 574178 574179 574180 574182 574230 574297 574300 574465 574466 574467 574468 574615 574735 574807 574858 574887 574893 574896 574912 574913 574925 574926 574950 574952 574979 574982 573109 573073 573072 574585 574586 574587 574588 574589 574590 574172 574173 574174 574175 574181 574183 574224 574227 574238 574239 574244 574245 574253 574254 574256 574258 574259 574267 574268 574269 574270 574271 574284 574295 574296 574313 574335 574336 574338 574392 574393 574394 574395 574396 574397 574398 574399 574400 574402 574403 574404 574405 574406 574407 574520 574536 574576 574577 574578 574579 574580 574591 574616 574618 574619 574620 574621 574675 574676 574677 574678 574681 574682 574683 574684 574685 574741 574829 574830 574831 574832 574865 574866 574867 574869 574879 574880 574881 571672 510520 512247 573221 575002 574225 574401 574194 574199 574371 574773 574774 574093 574094 574129 574202 574204 574211 574252 574257 574352 574201 574251 574261 574369 574476 574478 574495 574628 509167 570853 574330 574331 574469 574470 574471 574209 574213 5742

UPC codes

15099590265380

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.