Diagnostica Stago, Inc. recalls STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA…
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Read the official notice →- Date
- 2025-09-03
- Country
- United States
- Brand
- Diagnostica Stago
- Product
- STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Diagnostica Stago recalls
- 2026-03-25
USDiagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The…
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
FDA · DeviceDiagnostica Stago, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Singapore,…Official notice →- 2026-03-11
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Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description:…
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
FDA · DeviceDiagnostica Stago, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice → - 2026-01-21
- US
Diagnostica Stago, Inc. recalls Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of…
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
FDA · DeviceDiagnostica Stago, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, HI,…Official notice → - 2025-10-22
- US
Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di; REF: 00515;
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
FDA · DeviceDiagnostica Stago, Inc.Worldwide distribution- US Nationwide and the country of Canada.Official notice → - 2025-06-25
- US
Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and…
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
FDA · DeviceDiagnostica Stago, Inc.The affected lot was distributed to customers in various US states in October…Official notice → - 2023-05-17
- US
Diagnostica Stago, Inc. recalls STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the…
FDA · DeviceDiagnostica Stago, Inc.US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.Official notice →
Other drugs & medical recalls in the United States
- 2025-09-10
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- 2025-09-03
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR…
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CareFusion 303, Inc. recalls BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower /…
Antivirus software was not consistently installed on impacted devices during the implementation process.
FDA · DeviceCareFusion 303, Inc.Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL…
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS…
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C.R. Bard Inc recalls Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep…
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney…
FDA · DeviceC.R. Bard IncWorldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN,…Official notice →