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Displaying 1 - 10 of 10 items.
Vitros® Immunodiagnostic Products
Ortho Clinical Diagnostics has observed an increase in complaints, and confirmed observed imprecision, for low-level quality control (QC) and patient samples at the low end of the measuring (reportable) range when using Vitros FSH, LH and PROL reagent.…
RecallHealth product recall | 2022-04-11
Alinity I Homocysteine Reagent Kit
The purpose of this notification is to inform you of a product correction for the Alinity I Homocysteine Reagent Kits listed in the letter. Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of…
RecallHealth product recall | 2022-04-04
Immulite 2000 System-Human Chorionic Gonadotropin (HCG) Assay
Siemens Healthcare Diagnostics Inc. has confirmed the potential for falsely elevated hcg results due to sample carryover. This can be observed when a sample is assayed for HCG immediately after an undiluted sample with a HCG value of GT;5000 MIU/mL. This…
RecallHealth product recall | 2022-03-28
Atellica System
Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate…
RecallHealth product recall | 2022-03-14
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
Irispec Ca/Cb/Cc
Beckman Coulter has become aware of an increase in complaints generated for Irispec Ca failures for glucose on the ichemvelocity instrument. If a Qc run fails, the system will not allow the operator to run specimens. The Qc run should be repeated and be…
RecallHealth product recall | 2022-03-14
Architect "I" System - Stat Myoglobin Assay
The purpose of this recall is to inform the customer of a product recall for architect stat myoglobin calibrators, ln 2k43-01, lot number 166000. They have identified that this calibrator lot did not meet acceptance criteria during ongoing stability…
RecallHealth product recall | 2022-03-14
Vidas High Sensitive Troponin I (Tnhs)
Since January 2021, based on complaints received from the field related to critical non-repeatable overestimated results (changing interpretation according to the cutoff value, 19 ng/l, in the frame of the three hours algorithm that lead to a change in…
RecallHealth product recall | 2022-02-21
Vidas® Cmv Igm (Ref. 30205)
Invalid calibration leading to potential delayed results.
Recall start date: Feb 8, 2022
RecallHealth product recall | 2022-02-14