Randox Laboratories Ltd. recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus…
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.
Read the official notice →- Date
- 2024-01-10
- Country
- United States
- Brand
- Randox Laboratories
- Product
- SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus…
- Classification
- Class III
- Units
- NY, WV
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Randox Laboratories recalls
- 2024-01-24
USRandox Laboratories Ltd. recalls Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
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
- US
Randox Laboratories Ltd. recalls Calibration Serum Level 3 CAL2351
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%.
- US
Randox Laboratories Ltd. recalls Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
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…
- 2023-12-13
- US
Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of AR, GA, NC, TN, & PR.Official notice → - 2023-11-08
- US
Randox Laboratories Ltd. recalls RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
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…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution including Puerto RicoOfficial notice → - 2023-09-27
- US
Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
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…
Other drugs & medical recalls in the United States
- 2024-01-10
- US
Keystone Industries recalls KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints,…
Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use…
FDA · DeviceKeystone IndustriesWorldwide distribution - US Nationwide and the country of China.Official notice → - US
Merit Medical Systems, Inc. recalls Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B,…
The sterility of microcatheter and infusion system devices cannot be guaranteed.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT,…Official notice → - US
Encore Medical, LP recalls Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Mislabeling
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA,…Official notice → - US
Medtronic Inc. recalls Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Seal defects could compromise the ability of the product packaging to maintain sterility.
- US
ROi CPS LLC recalls Regard Dressing change kit, Item Number 800026006
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
- US
Busse Hospital Disposables, Inc. recalls Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be…