Beckman Coulter recalls Access 2 Immunoassay Analyzers (81600N) with nut bands that don't meet hardness specifications, potentially causing wash arm motion failures or inaccurate test results. Affected units manufactured from Dec 2017 to Oct 2022.
An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the firm's specifications for hardness and had the incorrect material grain direction. Affected instruments were manufactured from December 28, 2017 to October 19, 2022 or had their nut bands replaced during the same period.
Beckman Coulter is recalling Access 2 Immunoassay Analyzers that have nut bands not meeting hardness specifications. This could lead to wash arm motion failures, system check failures, or inaccurate patient test results. The issue was found in units manufactured from December 2017 through October 2022.
The nut bands in these analyzers were found to not meet the manufacturer's specifications for hardness and had incorrect material grain direction. This can cause wash arm motion failures, system check failures, or inaccurate patient test results during normal use.
Healthcare facilities using the Access 2 Immunoassay Analyzer (81600N) or refurbished models are affected. Patients using these analyzers for lab testing may experience delayed results or inaccurate test results if the nut band issue occurs.
Check if your Access 2 Immunoassay Analyzer has a serial number listed in the provided range (570512-571000) or the specific model numbers mentioned (81600N, 386220, A25640, A65531). The recall covers units manufactured from December 2017 to October 2022.
Verify if your Access 2 Immunoassay Analyzer has a serial number in the range 570512-571000 or the specific model numbers listed (81600N, 386220, A25640, A65531).
Beckman Coulter is recalling Access 2 Immunoassay Analyzers with nut bands that don't meet hardness specifications, which could cause wash arm motion failures, system check failures, or inaccurate patient test results.
The recall covers units manufactured from December 2017 through October 2022.
Check if your Access 2 Immunoassay Analyzer has a serial number in the range 570512-571000 or the specific model numbers listed (81600N, 386220, A25640, A65531).
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1257-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1257-2023 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
