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27 reported ongoing
35 records in this archive. Latest source date Jun 7, 2024.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Cystatin C Reagent marketed without a 510 (k)
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AL, CA, GA, NY.
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay ...
Class IIIReported ongoing
Distribution: US Nationwide distribution.
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Class IIReported ongoing
Distribution: Domestic: Nationwide Distribution.
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Class IIReported ongoing
Distribution: Domestic: CA, FL, IL, ME, NJ, OH, & OR.
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of CA, IN.
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of GA, MA, WV including PR.
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of GA, MA, WV including PR.
Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could ...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of SC and OK.
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Class IIReported ongoing
Distribution: US Nationwide and Puerto Rico.
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
Class IIReported ongoing
Distribution: US Nationwide including Puerto Rico.
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBI...
Class IIReported ongoing
Distribution: US Nationwide distribution.
A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
Class IIIReported ongoing
Distribution: NY, WV
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential...
Class IIReported ongoing
Distribution: US Nationwide distribution including Puerto Rico
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential...
Class IIReported ongoing
Distribution: US Nationwide distribution including Puerto Rico
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential...
Class IIReported ongoing
Distribution: US Nationwide distribution including Puerto Rico
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential...
Class IIReported ongoing
Distribution: US Nationwide distribution including Puerto Rico
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential...
Class IIReported ongoing
Distribution: US Nationwide distribution including Puerto Rico
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misrepo...
Class IIReported ongoing
Distribution: US States: GA, OH, OR, PA, TX, VA
As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into...
Class IIReported ongoing
Distribution: CA, FL, IL, ME, MI, NC, OH, PA,NJ,
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 35 records, including 27 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.