Randox Laboratories Ltd. recalls Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample…
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Read the official notice →- Date
- 2024-03-27
- Country
- United States
- Brand
- Randox Laboratories
- Product
- Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample…
- Classification
- Class II
- Units
- Domestic: CA, FL, IL, ME, NJ, OH, & OR.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-05-15
US
Randox Laboratories Ltd. recalls Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used…
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.
- 2024-04-24
US
Randox Laboratories Ltd. recalls Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
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…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of GA, MA, WV including PR.Official notice →- 2024-04-03
US
Randox Laboratories Ltd. recalls Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog…
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of CA, IN.Official notice →- 2024-02-14
US
Randox Laboratories Ltd. recalls RX Series Copper (Cu) Assay Ref. Number CU2340
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…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of SC and OK.Official notice →- 2024-01-24
US
Randox 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%.
Other drugs & medical recalls in the United States
- 2024-03-27
US
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
FDA · DeviceD.O.R.C. Dutch Opthalmic Research Center Intl B.V.US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH,…Official notice →US
Covidien recalls Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to…
FDA · DeviceCovidienUS Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL,…Official notice →US
Baxter Healthcare Corporation recalls HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for…
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Florida.Official notice →US
Thommen Medical AG recalls impression coping, repositionable, short, screw-retained, PF 4.0
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
FDA · DeviceThommen Medical AGUS Nationwide distribution in the states of OH and KY.Official notice →US
Preat Corp recalls Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
US
In2Bones, SAS recalls I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the…