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Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium

Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium Recalls

All product recalls associated with Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium.

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Recall Summary

Total Recalls

1000

Past Year

426

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 441–460 of 4598 recalls

Idylla Instrument (Biocartis) – False-Positive MSI-H Results (2024)

False-positive MSI-H results generated by the Idylla MSI Test.

Moderate

FDADec 10, 2024AL, CA, NJ +2 more• Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium

Regener-Eyes Ophthalmic Solution (Regenerative Processing) – Sterility Risk (2024)

Lack of Sterility Assurance

Class IIModerate

FDADec 10, 2024Nationwide• Regenerative Processing Plant, LLC

Portrait Core Services (GE Medical) – Patient Monitoring Software Failure (2024)

There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.

Moderate

FDA

1...21 222324 25...230

Page 23 of 230Next

Dec 6, 2024

Nationwide

• GE Medical Systems, LLC

Duloxetine Capsules 30mg (Breckenridge) – CGMP Impurity Limit (2024)

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules 60mg (Breckenridge) – CGMP Impurity Limit (2024)

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Class IIModerate

FDADec 6, 2024Nationwide• Breckenridge Pharmaceutical, Inc

LINK MP Reconstruction System (Waldemar Link) – Incorrect Label Size (2024)

Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).

Low

FDADec 5, 2024Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Hillrom Temperature Management Controller (Augustine) – Instructions Update (2024)

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

Moderate

FDADec 4, 2024Nationwide• Augustine Temperature Management, LLC

Hot Dog Patient Warming Controller (Augustine) – Instructions Update (2024)

Moderate

FDADec 4, 2024Nationwide• Augustine Temperature Management, LLC

FastPack SHBG Immunoassay (Qualigen) – Incorrect Expiration Date (2024)

Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.

Low

FDADec 3, 2024AR, CA, CO +12 more• Qualigen Inc

Boar's Head Hummus Veg Platter (Kroger) – Salmonella Contamination (2024)

Salmonella

Platters and trays prepared in-store may contain cut cucumbers that were previously recalled due to potential contamination with Salmonella.

Class IHigh

FDANov 29, 2024AZ, CO, LA +4 more• The Kroger Co

Boar's Head Hummus Veg Platter (Kroger) – Salmonella Cross-Contamination (2024)

Salmonella

Platters and trays prepared in-store may contain cut cucumbers that were previously recalled due to potential contamination with Salmonella.

Class IHigh

FDANov 29, 2024AZ, CO, LA +4 more• The Kroger Co

Deli Fresh Vegetable Tray (Kroger) – Salmonella Contamination (2024)

Salmonella

Platters and trays prepared in-store may contain cut cucumbers that were previously recalled due to potential contamination with Salmonella.

Class IHigh

FDANov 29, 2024AZ, CO, LA +4 more• The Kroger Co

Small Veggie Platter (Kroger) – Contaminated Cucumber Risk (2024)

Salmonella

Platters and trays prepared in-store may contain cut cucumbers that were previously recalled due to potential contamination with Salmonella.

Class IHigh

FDANov 29, 2024AZ, CO, LA +4 more• The Kroger Co

Surgical Sheath 20 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 20 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 18 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 18 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

GE Optima XR220amx (GE Medical) – Column Bolt Issue (2024)

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

High

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

GE Optima XR200amx (GE Medical) – Column Bolt Issue (2024)

High

FDANov 25, 2024Nationwide• GE Medical Systems, LLC

GE Optima XR240amx (GE Medical) – Column Bolt Issue (2024)

High

FDANov 25, 2024Nationwide• GE Medical Systems, LLC