FDA Removes Blood Testing Tubes, Other Supplies From Medical Device Shortage List

The Food and Drug Administration removed several products used in blood collection and transfusion from the medical device shortages list in a July 14 update.

In the category of “Specimen Collection – Testing Supplies and Equipment,” the agency removed the following products:

• Tubes, vials, systems, serum separators, blood collection (product code JKA).
• Tubes, vacuum sample, with anticoagulant (product code GIM).
• Absorbent tipped applicator (product code KXG).

In the category of “Laboratory Reagents and Testing Supplies,” FDA removed the following products:

• Micro pipette (product code JRC).
• Equipment, laboratory, general purposes, labeled or promoted specifically for medical use, pipette tips only (product code LXG).
• General purpose reagents for in vitro diagnostic tests, including pipette tips (product code PPM).
• Multi-target respiratory specimen nucleic acid test including SARS-COV-2 and other microbial agents (product code QOF).
• Instrumentation for clinical multiplex test system (product code NSU).
• Real-time nucleic acid amplification system (product code OOI).
• Clinical sample concentrator (product code JJH).

The update also removed the following products related to transport media devices:

• Culture media, non-propagating (product code JSM).
• Microbiological specimen collection and transport device (product code LIO).
• Microbial nucleic acid storage and stabilization device (product code QBD).

Additional information about the medical device supply chain and shortages is available online.