PlainRecordsDxI 9000 Access Immunoassay Analyzer…
- Reason
- A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in…
- Status
- Ongoing
- Distribution
- Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great Britain and Northern…
- Enforcement report date
- June 18, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Beckman Coulter, Inc.
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
- Reason
- A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
- Distribution pattern
- Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great Britain and Northern Ireland, Hungary, Austria, Portugal, Croatia, Kazakhstan, Cote d'lvoire, Poland, Korea, Republic of, Czechia, Algeria, Libya, Oman, Singapore, and Belgium.
- Quantity
- 324 units
- Codes and lots
- UDI-DI: 15099590732103; Serial Numbers: 300144 300145 300148 300150 300153 300154 300155 300156 300157 300158 300161 300166 300168 300171 300174 300175 300178 300182 300183 300186 300190 300191 300192 300193 300194 300198 300200 300201 300204 300205 300206 300208 300209 300210 300211 300212 300213 300214 300215 300217 300218 300219 300221 300225 300226 300228 300231 300232 300234 300235 300236 300240 300242 300249 300250 300252 300255 300266 300267 300270 300272 300273 300274 300275 300279 300280 300282 300283 300284 300285 300286 300288 300293 300299 300300 300306 300309 300312 300314 300316 300317 300318 300319 300322 300323 300326 300327 300328 300329 300331 300333 300334 300336 300338 300339 300341 300346 300350 300352 300354 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 300455 300457 300458 300464 300467 300468 300470 300474 300475 300476 300479 300481 300489 300490 300491 300493 300495 300496 300497 300500 300501 300506 300507 300508 300509 300510 300511 300512 300514 300515 300516 300517 300518 300519 300520 300521 300522 300523 300524 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 300566 300567 300568 300569 300570 300571 300572 300573
- Recall started
- April 23, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- An "URGENT MEDICAL DEVICE RECALL (UMDR)" notification letter dated 4/16/25 was sent to customers. ACTION: If your laboratory encounters the system event described in this letter: Perform a system initialization to resume normal operation. Repeat testing for any canceled tests. No action is required if your laboratory has not observed the system event listed above. RESOLUTION: Beckman Coulter will release a modification for this issue. Your service representative will schedule the modification installation when it is available. 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 Customer Support Center: From our website: http://www.beckmancoulter.com
- Recall number
- Z-1926-2025
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.”DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20, FDA enforcement report, 2025-06-18. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.
FDA device name: Radioimmunoassay, Thyroid-Stimulating Hormone
This recall among the others
- FDA's enforcement report came 56 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Beckman Coulter: 48 other recalls or notices on this site in the three years before this one (from June 19, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1926-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1926-2025, June 18, 2025. "DxI 9000 Access Immunoassay Analyzer." PlainRecords, https://plainrecords.com/recall/device/z-1926-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections