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.
Read the official notice →- Date
- 2026-03-25
- Country
- United States
- Brand
- Diagnostica Stago
- Product
- Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 2026-03-11
- US
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 → - 2025-09-03
- 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
- 2026-04-01
- US
- 2026-03-25
- US
Datascope Corp. recalls Battery Charging Station; Model: 0998-00-0802;
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in…
FDA · DeviceDatascope Corp.Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN,…Official notice → - US
Hologic, Inc. recalls Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Due to product exhibiting potential to generate either invalid or false negative results.
FDA · DeviceHologic, Inc.U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR,…Official notice → - US
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
FDA · DeviceConvaTec, IncWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - US
Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta…
Due to adapter not being properly aligned or locked in place.
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AZ,…Official notice → - US
Stryker Medical Division of Stryker Corporation recalls Cub Pediatric Crib, Model FL19H
Cribs sold in the USA are missing two access door warning labels.
FDA · DeviceStryker Medical Division of Stryker CorporationUS Nationwide distribution.Official notice →