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Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel

Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel Recalls

All product recalls associated with Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel.

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Recall Summary

Total Recalls

1000

Past Year

304

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 4641–4660 of 4747 recalls

Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel: Crosseal, fibrin sealant (human), This package***, One Ap...

5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .

FDAAug 6, 2004Nationwide• Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel

Ortho-Clinical Diagnostics: VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box...

The Immuno-rate (IR) wash detection algorithm may result in inappropriate wash detections.

FDAJul 28, 2004Nationwide• Ortho-Clinical Diagnostics

Abbott Laboratories Diagnostic Div: Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creati...

Precipitate formed in product.

1...231 232233234 235...238

Page 233 of 238Next

FDA

Jul 27, 2004

Nationwide

• Abbott Laboratories Diagnostic Div

Roche Diagnostics Corp.: Roche brand Reflotron GOT (AST), 30 test strips; catalog ...

Coating defect may result is falsely decreased patient and/or control results.

FDAJul 14, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche brand Reflotron GPT (ALT) 30 test strips; catalog #...

Coating defect may result is falsely decreased patient and/or control results.

FDAJul 14, 2004Nationwide• Roche Diagnostics Corp.

Fisher Diagnostic, A Company of Fisher Scientific LLC: Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics ...

Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.

FDAJul 1, 2004Nationwide• Fisher Diagnostic, A Company of Fisher Scientific LLC

Nichols Institute Diagnostics: Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog num...

Lower than expected results are obtained.

FDAJun 30, 2004Nationwide• Nichols Institute Diagnostics

Roche Diagnostics Corp.: ACCU-CHEK Inform base unit; catalog no. 3035131.

Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

FDAJun 30, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: ACCU-CHEK Inform meter; catalog No. 3035123.

Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

FDAJun 30, 2004Nationwide• Roche Diagnostics Corp.

ABX Diagnostics Inc: PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

Power failure having impact on software.

FDAJun 24, 2004Nationwide• ABX Diagnostics Inc

Roche Diagnostics Corp.: Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit...

May report falsely decreased patient results.

FDAJun 18, 2004Nationwide• Roche Diagnostics Corp.

Ortho-Clinical Diagnostics: Vitros Immunodiagnostic Products TROPONIN I Reagent Packs...

Random occurrence of false positive test results.

FDAJun 7, 2004Nationwide• Ortho-Clinical Diagnostics

Roche Diagnostics Corp.: Disetronic brand 3.15 ml glass cartridges used with H-tro...

Lack of assurance of sterility.

FDAMay 17, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Disetronic brand 5 ml. glass cartridges used with the Pan...

Lack of assurance of sterility.

FDAMay 17, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Tecan clinical workstation; 10-410 Tecan Genesis 150 back...

Tecan software has the potential to match the patient with a different patient's test results.

FDAMay 5, 2004Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: COBAS Gui software interface between the Cobas AMPLICOR i...

The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.

FDAMay 5, 2004CA, CT, IL +4 more• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Tecan clinical workstation; Tecan Genesis 150/8 front end...

Tecan software has the potential to match the patient with a different patient's test results.

FDAMay 5, 2004Nationwide• Roche Diagnostics Corp.

Diagnostic Products Corp: Immulite 1000 CEA Catalog No. LKCE1

Instabililty

FDAMay 3, 2004Nationwide• Diagnostic Products Corp

ABX Diagnostics Inc: Pentra 80 and Pentra 80XL Hematology Analyzers

Software defect, instrument may erroneously give a result of '0' or '---'.

FDAApr 8, 2004Nationwide• ABX Diagnostics Inc

Allergan Medical Optics Inc: Surgical Tubing Pack, Model: AMO Prestige Pack, Product C...

The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.

FDAMar 29, 2004Nationwide• Allergan Medical Optics Inc