Reported Mar 22, 2023 · Ongoing
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished…
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N) |
| 2 | (2) Access 2 Immunoassay Analyzer, Refurbished (386220) |
| 3 | (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) |
| 4 | and (4) Access 2 Section, DxC 600i Packaged(A25640). |
- Lot codes and dates
- UDI number for the Access 2 instruments
15099590265380. No UDI for Access 2 SectionDxC 60i PackagedCatalog #A25640
- PN 81600N serial numbers
3,278 of 3,278 codes
570512570513570514570515570516570517570518570519570520570521570522570523570524570525570526570527570528570529570530570531570532570533570534570535570536570537570538570539570540570541570542570543570544570545570546570547570548570549570550570551570552570553570554570557570559570560570562570563570564570565570566570567570568570569570570570571570572570573570574570575
- PN 386220 serial numbers
845 of 845 codes
500675501192501325501446501647501922502049502132502245502294502365502421502437502656502676502742502907502968502977503059503083503097503137503141503156503298503337503343503345503369503374503378503461503508503532503564503599503601503608503672503706503763503771503823503974504078504137504147504174504192504233504326504358504370504461504490504540504622504655504666
- PN A25640 serial numbers
800918800937800938800939800946800947800948800971
- PN A65531 serial numbers800989 801076
- UDI number for the Access 2 instruments
- Amount recalled
- 4,137 devices (990 U.S. and 3,147 OUS)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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