CLASS II Device recall · Reported 22 Jun 2016 · FDA Enforcement Report
Access 2 Immunoassay System, Remanufactured recalled by Beckman Coulter
Beckman Coulter is recalling Access 2 Immunoassay System, Remanufactured. The recall was initiated on 17 May 2016 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-1956-2016
- FDA event ID
- 74212
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 May 2016
- FDA classified
- 13 Jun 2016
- Reported
- 22 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Test Kits & Diagnostics
Timeline
| 17 May 2016 | Recall initiated by company | |
| 13 Jun 2016 | Classified by FDA | +27 days |
| 22 Jun 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
Where it was distributed
US, Morocco, Venezuela
Questions about this recall
Why was it recalled?
Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.
Which lots are affected?
Serial No. 505143, 504805, 501368, 504231
Where was it sold?
US, Morocco, Venezuela
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 26 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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