CLASS II Device recall · Reported 12 Apr 2017 · FDA Enforcement Report
Access 2 assay Immunoassay System, Remanufactured recalled
Beckman Coulter is recalling Access 2 assay Immunoassay System, Remanufactured, distributed in Puerto Rico. The recall was initiated on 7 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1710-2017
- FDA event ID
- 76688
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Mar 2017
- FDA classified
- 4 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Mar 2017 | Recall initiated by company | |
| 4 Apr 2017 | Classified by FDA | +28 days |
| 12 Apr 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Where it was distributed
Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe
Questions about this recall
Is Access 2 assay Immunoassay System, Remanufactured recalled?
Yes. Beckman Coulter recalled Access 2 assay Immunoassay System, Remanufactured on 7 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1710-2017.
Why was it recalled?
Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.
Which lots are affected?
Serial No. 501012,501110,501190,501224,501294,501371,501394,501403,501440, 501443,501490,501501,501673,501681,501693,501861,501920,501926, 501936,501970,502165,502196,502319,502331,502332,502368,502458, 502475,502506,502543,502549,502556,502574,502640,502647,502651, 502791,502843,502848,503153,503279,503313,503354,503384,503392, 503424,503543,503627,503678,504046,504071,504072,504092,504112, 504195,504322,504365,504370,504756,504767,504902,505042,505195, 505251,505254,505644,505795,505840,505947,506002,506026,506108, 506119,506153,506187,506371,506406,506560,506586,506664,506708, 506766,506786,506837,506846,507039,507120,507161,507162,507214, 507229,507248,507282,507353,507397,507480,507511,507604,507619, 507842,507929,508019,508096,508179,508227,508313,508334,508412, 508478,508509,508516,508767,509051,509087,509113,509164,509253, 509297,509632,509837,510049,511042,511047,511180,511383,700024, 800321,800341,800443,800608,800611,800650,800849
Where was it sold?
Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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