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Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics Recalls

All product recalls associated with Ortho-Clinical Diagnostics.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

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 20501–20520 of 21319 recalls

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

Siemens Medical Solutions USA, Inc: Magnetom Trio MRI System, Model 7106441

An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

FDAJul 28, 2004CA, CO, CT +19 more• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: Magnetom Symphony MRI System, Model 7106557

An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows

FDAJul 28, 2004

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CA, CO, CT +19 more

• Siemens Medical Solutions USA, Inc

Greiner VACUETTE North America: Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3...

Coagulation tubes may not have received the proper fill of citrate solution.

FDAJul 27, 2004Nationwide• Greiner VACUETTE North America

PTAC Air Conditioning Units (Friedrich) – Manufacturing Problem (2004)

Fire/Burn Risk

The recall includes all PTAC units in the P series with dates of manufacture between November 1, 2002, and December 31, 2003. The model and serial numbers are written on the nameplate, found behind the plastic front cover, directly below the control panel. Units with serial number LBLP00001 through LCMP9999 are included in the recall. Also included in the recall are "P Series" units that were serviced between June 1, 2003, and December 31, 2003, in which service included the field replacement of the heater assembly. The Friedrich "P Series" PTAC is a light beige color with the "FRIEDRICH" logo on the panel door.

CPSCJul 27, 2004Nationwide• Friedrich Air Conditioning Co., of San Antonio, Texas

Advanced Bionics Corporation: Auria PowerPak, Model CI-7400-xxx where xxx denotes color...

Fire/Burn Risk

Battery pack may overheat and cause patient burns.

FDAJul 27, 2004Nationwide• Advanced Bionics Corporation

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

Precipitate formed in product.

FDAJul 27, 2004Nationwide• Abbott Laboratories Diagnostic Div

Medtronic Inc, Neurological & Spinal Division: The Model 8540 Catheter Access Port Kit is intended for u...

The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293.

FDAJul 23, 2004IN• Medtronic Inc, Neurological & Spinal Division

Philips Medical Systems Sales & Service Region No. America: BV212 Mobile X-Ray System

Potential for c-arm to move due to loose screws

FDAJul 20, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Philips Medical Systems Sales & Service Region No. America: BV29 Mobile X-Ray System

Potential for c-arm to move due to loose screws

FDAJul 20, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Philips Medical Systems Sales & Service Region No. America: BV26 Mobile X-Ray System

Potential for c-arm to move due to loose screws

FDAJul 20, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Merit Medical Systems, Inc: Merit MAK Mini Access Kit, 4 French (1.3mm)

Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.

FDAJul 20, 2004Nationwide• Merit Medical Systems, Inc

Lawn Tractors (Simplicity) – Mechanical Repair Needed (2004)

Laceration Risk

These lawn tractors and riding mowers, designed for non- commercial use, were sold under the Simplicity, AGCO and Massey Ferguson brand names. They include Regent/500/2500 Series lawn tractors, Coronet/2400 Series riding mowers, and Lancer/4400 Series riding mowers with the following model and serial numbers: Regent/500/2500 Series: Product Series Model Number Serial Number Regent, 15-hp 1693911 09000-09439 Regent, 15-hp 1694321 09000-10015 Regent, 15-hp 1694314 00166-00334 Regent, 16-hp 1693915 09000-11368 Regent, 16-hp 1694200 09000-09120, 10000-10411 Regent, 16-hp 1694313 09000-09060, 10000-10001 Regent, 17-hp 1693918 09000-09050 515H, 15-hp 1694323 09000-09027 516H, 16-hp 1693935 09000-09034 2515H, 15-hp 1694325 09000-09011 2526H, 16-hp 1694343 09000-09025 </tr> Coronet/2400/RT Series: Product Series Model Number Serial Number Coronet, 13-hp 1694462 00001-00599 Coronet, 16-hp 1694463 00001-00346 Coronet, 13-hp 1694510 00001-00098 2413H, 13-hp 1694464 00001-00028 Lancer/4400 Series: Product Series Model Number Serial Number Lancer, 17-hp 1694292 02000-02016 4417, 17-hp 1694294 02000-02160

CPSCJul 20, 2004Nationwide• Simplicity Manufacturing Inc., of Port Washington, Wis.

Chrome Dumbbells (Reebok NordicTrack) – Weight Safety Issue (2004)

The chrome dumbbells weigh between 2 and 50 pounds and have the Reebok or NordicTrack trademark name on the outside of the bells, along with the weight of the dumbbell.

CPSCJul 20, 2004Nationwide• Coaster Co. of America, Santa Fe Springs, Calif.

Philips Medical Systems Sales & Service Region No. America: BV25 Mobile X-Ray System

Potential for c-arm to move due to loose screws

FDAJul 20, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Philips Medical Systems Sales & Service Region No. America: BV 25 Gold Mobile X-Ray System

Potential for c-arm to move due to loose screws

FDAJul 20, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

Boston Scientific Corporation: Express 2 Monorail Coronary Stent Systems (bare metal ste...

Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.

FDAJul 16, 2004Nationwide• Boston Scientific Corporation

Bock, Otto, Orthopedic Ind, Inc: Modular Knee Joint with Friction Brake

Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the braking performance of the knee to malfunction.

FDAJul 15, 2004Nationwide• Bock, Otto, Orthopedic Ind, Inc

Wright Medical Technology Inc: Guardian Distal Femur Axial Pin

Potential for self -locking axial pin to dislodge and 'back out'.

FDAJul 14, 2004Nationwide• Wright Medical Technology Inc

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.