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VITROS XT TBIL-ALKP Slides (Ortho-Clinical) – Substrate Depletion (2023)

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

Moderate

FDAAug 5, 2023Nationwide• Ortho-Clinical Diagnostics, INc.

Altivate Reverse Humeral Stem (DJO) – Sterilization Omission (2023)

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

Moderate

FDAAug 4, 2023AL, AZ, CA +23 more

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VITROS XT TBIL-ALKP Slides (Ortho-Clinical) – Substrate Depletion (2023)

Altivate Reverse Humeral Stem (DJO) – Sterilization Omission (2023)

Hudson RCI Addipak (Medline) – Sterility Failure (2023)

Reverse Shoulder System Socket Insert (DJO Surgical) – sterilization issue (2023)

CLP Hip Stem (DJO Surgical) – sterilization issue (2023)

Delta Ceramic Femoral Head (DJO Surgical) – sterilization issue (2023)

Empowr Knee Baseplate (DJO Surgical) – sterilization issue (2023)

Upper Roller Bracket (Accuray) – service clearance problem (2023)

ReNewal Ligasure Sealer (MEDLINE) – packaging seal issue (2023)

Gammex Non-Latex PI Green Surgical Gloves (Ansell) – pouch seal issue (2023)

Novaplus Gammex Non-Latex PI Green Surgical Gloves (Ansell) – pouch seal issue (2023)

ReNewal Ligasure Maryland Jaw Sealer (MEDLINE) – packaging seal issue (2023)

ReNewal Ligasure Blunt Tip Sealer (MEDLINE) – packaging seal issue (2023)

3T Heater Cooler System (LivaNova) – maintenance schedule error (2023)

Sterile Iris Scissors (MEDLINE) – tip protector risk (2023)

Liquid Assayed Chemistry Control (Randox) – instructions error (2023)

ReNewal Harmonic ACE+7 Shears (MEDLINE) – packaging seal issue (2023)

Incisive CT (Philips) – software compliance concerns (2023)

SynCardia 50cc TAH-t (SynCardia) – unapproved epoxy resin (2023)

COOLIEF RF Generator (Avanos) – equipment fault increase (2023)