Microgenics Corporation recalls MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed…
Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient…
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- Microgenics
- Product
- MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of UT, MI, OK, NY, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Microgenics recalls
- 2025-11-05
Microgenics Corporation recalls Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303,…
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
FDA · DeviceMicrogenics CorporationWorldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI,…Official notice →- 2022-07-06
Microgenics Corporation recalls QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL…
Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.
FDA · DeviceMicrogenics CorporationU.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC,…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-21
Cook Incorporated recalls Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part…
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of…
FDA · DeviceCook IncorporatedUS States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain,…Official notice →Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display…
FDA · DeviceMagellan Diagnostics, Inc.US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.Official notice →Beckman Coulter, Inc. recalls DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution including in the states and territory…Official notice →W L Gore & Associates, Inc. recalls Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The…
The potential for the devices to be mislabeled with the incorrect length.
FDA · DeviceW L Gore & Associates, Inc.US Nationwide distribution in the states of GA, RI.Official notice →In2bones USA, LLC recalls REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
FDA · DeviceIn2bones USA, LLCUS Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.Official notice →Steris Corporation recalls RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted…