Recall Z-1386-2025
Beckman Coulter, Inc. · initiated February 5, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Codes / lots: 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…
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
An URGENT MEDICAL DEVICE RECALL notification letter dated 1/31/25 was sent to customers. If the error occurs: 1. Confirm the system is in the Ready or Not Ready mode. 2. Go to the Initialize System window. To get to this window from the Main Menu, select Diagnostics F7 to display the Diagnostics menu, then select Initialize System F1. The Initialize System window is displayed with a confirmation message. 3. Select Yes F1 to initialize the instrument. Contact your Beckman Coulter representative if your laboratory has experienced sample carousel motion errors that are not resolved by initializing the analyzer. Your Beckman Coulter service representative will replace the sample motor during your next semi-annual preventative maintenance or repair visit. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support: From our website: http://www.beckmancoulter.com
Details
- Recall number
- Z-1386-2025
- Initiated
- February 5, 2025
- Posted by FDA
- March 17, 2025
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 873 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- Beckman Coulter, Inc., Chaska, MN