Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 22, 2023
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter, Inc. recalled Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 I… - a moderate-severity action.
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 I… was recalled by Beckman Coulter, Inc. in March 22, 2023. Reason: An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of…. Check the official notice for the remedy. Verify recall #Z-1257-2023 with the FDA Devices before acting.
The recall
Beckman Coulter, Inc. issued this moderate-severity FDA Devices recall-An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- March 22, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1257-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1257-2023) was formally reported on March 22, 2023, with the manufacturer initiating the action on January 26, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter, Inc. is listed as the recalling firm, operating out of Chaska, MN. Federal records list the affected scope as 4,137 devices (990 U.S. and 3,147 OUS).
The documented reason for this recall is: 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 performanc… Distribution data in the federal record shows the product reached: Worldwide and Nationwide Distribution. There was government/military distribution. Foreign distribution was made to Algeria, Andorra, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Bonaire, Bosnia and Herzegovin…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4,137 devices (990 U.S. and 3,147 OUS)
Related Recalls
6
3 from same agency
Product description
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1257-2023 |
| Date reported | March 22, 2023 |
| Date initiated | January 26, 2023 |
| Recalling firm | Beckman Coulter, Inc. |
| Firm location | Chaska, MN |
| Affected scope | 4,137 devices (990 U.S. and 3,147 OUS) |
| Distribution | Worldwide and Nationwide Distribution. There was government/military distribution. Foreign distribution was made to Algeria, Andorra, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Bonaire, Bosnia and Herzegovina, Botswana, Brazil,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1257-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).. Recalled by Beckman Coulter, Inc.. Units affected: 4,137 devices (990 U.S. and 3,147 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2023. Severity: Moderate. Recall number: Z-1257-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide and Nationwide Distribution. There was government/military distribution. Foreign distribution was made to Algeria, Andorra, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Bonaire, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Macao, Malawi, Malaysia, Maldives, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E, Uganda, Ukraine, United Kingdom, Uruguay, Vietnam, Yemen, Zambia, and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1257-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 22, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.