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RecallWatchMedical Device Safety
Class IIOngoingZ-1996-2025

Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137

Beckman Coulter, Inc.Chaska, MN, United StatesReported Jul 2, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • DxI 9000 Access Immunoassay AnalyzerC11137
    UDI-DI 15099590732103
    246 affected lots
    300116300124300126300128300132300136300138300144
    +238 more300145300148300150300153300154300155300156300157300158300161300166300168300171300174300175300178300179300182300183300186300190300191300192300193300194300198300200300201300204300205300206300207300208300209300210300211300212300213300214300215300217300218300219300221300225300226300228300231300232300234300235300236300240300242300246300249300250300252300255300266300267300270300272300273300274300275300279300280300282300283300284300285300286300288300293300299300300300306300307300308300309300312300314300316300317300318300319300321300322300323300326300327300328300329300331300333300334300336300338300339300341300346300350300352300354300355300356300358300359300360300361300362300370300372300373300375300376300378300388300389300392300393300395300396300397300398300403300407300408300409300410300411300413300414300415300420300422300423300424300425300426300427300428300430300434300438300446300454300455300457300458300461300464300467300468300470300474300475300476300479300481300483300489300490300491300493300495300496300497300500300501300506300507300508300509300510300511300512300514300515300516300517300518300519300521300522300523300525300526300527300528300530300531300532300533300534300535300536300537300538300539300540300541300542300543300544300546300547300548300551300552300553300554300555300556300557300558300559300560300561300562300563300564300565300566300567300568300569300570300571300572300573300574300575300576300577300578300579

What the firm is doing

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.

DistributionShow details

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, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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