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.
Read the official notice →- Date
- 2026-03-11
- Country
- United States
- Brand
- Diagnostica Stago
- Product
- Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-09-09
USDiagnostica Stago, Inc. recalls STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
FDA · DeviceDiagnostica Stago, Inc.US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA,…Official notice →- 2026-03-25
- US
Diagnostica 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 → - 2026-01-21
- 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 → - 2025-09-03
- US
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.
FDA · DeviceDiagnostica Stago, Inc.Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL,…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 →
Other drugs & medical recalls in the United States
- 2026-03-11
- US
Olympus Corporation of the Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System -…
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards…
FDA · DeviceOlympus Corporation of the AmericasInternational distribution in the country of Canada, Germany, Singapore,…Official notice → - US
Advanced Bionics, LLC recalls Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Behind-the-ear sound processer packaging label is different then included product.
- US
Vascutek, Ltd. recalls Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE,…
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of…
FDA · DeviceVascutek, Ltd.US Nationwide distribution including in the states of FL, PA, TX, NC, NY, CA,…Official notice → - US
ESAOTE S.P.A. recalls Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
- US
Olympus Corporation of the Americas recalls Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be…
Potential for rubber fragment detachment during use.
- US
Datascope Corp. recalls CS300 IABP. Software Version CS300 IABP C.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
FDA · DeviceDatascope Corp.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →