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Displaying 1 - 8 of 8 items.
Access System - Free T3 Assays
Beckman Coulter has determined that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are…
RecallHealth product recall | 2023-03-29
Access 2 Immunoassay Analyzer
Beckman Coulter has determined that the Access 2 wash arm lead screw nut band is susceptible to breakage. An Access 2 Immunoassay system wash arm may not move as intended if the nut band is broken. A broken nut band may increase the risk of erroneous…
RecallHealth product recall | 2023-01-31
Leukosure Enumeration Kit
Affected lots of Leukosure enumeration kit may not be able to acquire 10,000 leukosure fluorosphere events within 300 seconds as outlined in the statement of warnings in the product instructions for use (IFU) pn 175624 revision ee. The issue is due…
RecallHealth product recall | 2022-12-15
Kaluza C Software
Beckman Coulter has discovered software anomalies in Kaluza C that may lead to the generation of erroneous results.
Recall start date: June 28, 2021
RecallHealth product recall | 2022-07-25
Iq Calibrator Pack and Control/Focus Set
Beckman Coulter has identified that order number(s) 41231574 and 41231557 for the shipment of Iq200 Control/Focus Set (part number 800-3104, lot# 146-21) and Iq200 Calibrator (part number 800-3103, lot# 146-21) were inadvertently frozen prior to shipment…
RecallHealth product recall | 2022-03-14
Access Hstni
FA-000604, which was distributed in August 2021, notified customers of possible intra-assay carryover. The letter communicated that clinically significant carryover into a reagent pack (into-pack) can occur if an Access Hstni test is performed after a…
RecallHealth product recall | 2022-03-14
Beckman Coulter Immunochemistry System - Magnesium Assay
Internal testing determined that magnesium failed to meet the interference claim as per ifu for the lipemic serum interference. all lots of magnesium osr6189 are affected.
Recall start date: 2021-12-06…
RecallHealth product recall | 2021-12-31
UniCel DxI 800 Access Immunoassay System
One shipment of the affected lot was frozen and thawed prior to shipment.
Recall date: 2021-10-07
RecallHealth product recall | 2021-10-29