Recall Z-1996-2025
Beckman Coulter, Inc. · initiated May 7, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DxI 9000 Access Immunoassay Analyzer C11137
Codes / lots: 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…
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: Software design
Action taken
The 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.
Details
- Recall number
- Z-1996-2025
- Initiated
- May 7, 2025
- Posted by FDA
- June 20, 2025
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 67 US; 178 OUS
- Distribution
- Worldwide - 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…
- Recalling firm
- Beckman Coulter, Inc., Chaska, MN