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U.S. Department of Health and Human Services

Class 2 Device Recall DxI 9000 Access Immunoassay Analyzer

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 Class 2 Device Recall DxI 9000 Access Immunoassay Analyzersee related information
Date Initiated by FirmMay 07, 2025
Date PostedJune 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1996-2025
Recall Event ID 96876
510(K)NumberK221225 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductDxI 9000 Access Immunoassay Analyzer C11137
Code Information UDI-DI 15099590732103 Serial Numbers 300116 300124 300126 300128 300132 300136 300138 300144 300145 300148 300150 300153 300154 300155 300156 300157 300158 300161 300166 300168 300171 300174 300175 300178 300179 300182 300183 300186 300190 300191 300192 300193 300194 300198 300200 300201 300204 300205 300206 300207 300208 300209 300210 300211 300212 300213 300214 300215 300217 300218 300219 300221 300225 300226 300228 300231 300232 300234 300235 300236 300240 300242 300246 300249 300250 300252 300255 300266 300267 300270 300272 300273 300274 300275 300279 300280 300282 300283 300284 300285 300286 300288 300293 300299 300300 300306 300307 300308 300309 300312 300314 300316 300317 300318 300319 300321 300322 300323 300326 300327 300328 300329 300331 300333 300334 300336 300338 300339 300341 300346 300350 300352 300354 300355 300356 300358 300359 300360 300361 300362 300370 300372 300373 300375 300376 300378 300388 300389 300392 300393 300395 300396 300397 300398 300403 300407 300408 300409 300410 300411 300413 300414 300415 300420 300422 300423 300424 300425 300426 300427 300428 300430 300434 300438 300446 300454 300455 300457 300458 300461 300464 300467 300468 300470 300474 300475 300476 300479 300481 300483 300489 300490 300491 300493 300495 300496 300497 300500 300501 300506 300507 300508 300509 300510 300511 300512 300514 300515 300516 300517 300518 300519 300521 300522 300523 300525 300526 300527 300528 300530 300531 300532 300533 300534 300535 300536 300537 300538 300539 300540 300541 300542 300543 300544 300546 300547 300548 300551 300552 300553 300554 300555 300556 300557 300558 300559 300560 300561 300562 300563 300564 300565 300566 300567 300568 300569 300570 300571 300572 300573 300574 300575 300576 300577 300578 300579
FEI Number 2122870
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information ContactIan Pilcher
952-448-4848
Manufacturer Reason
for Recall		Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
FDA Determined
Cause 2		Software design
ActionThe firm began notifying customers the week of May 7, 2025 via Urgent Medical Device Recall letters. Only analyzers running software version 1.20 are affected. Customers were provided with instructions on what to do if they observe a calibration that remains in the "In Progress" or "Presented" state. Beckman Coulter will release a service modification to change a configuration setting to prevent this issue. Your service representative will schedule the service modification installation when it is available. In the meantime, it is recommended that customers share the content of this letter with your laboratory and/or medical director to determine if a review of previous patient test results is necessary. Beckman Coulter recommends posting the recall letter on or near the affected systems until corrections have been made.
Quantity in Commerce67 US; 178 OUS
DistributionWorldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI, ID, IL, IN, KY, LA, ME, MI, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, WA, WI and the countries of Algeria, Australia, Austria, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Libya, New Zealand, Oman, Poland, Portugal, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJE
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