Wand, Bar Code 00024015859Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

26 other recalls cover devices cleared under the same FDA submission (K160412, K203790); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 8, 2026Open, Classified

   BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.

   Z-2822-2026 · Root cause: Software Design Change · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160412, K203790. One submission often covers many models, so check the product and lot details in each record.

• Z-2900-2026 · May 21, 2026 · Open, Classified
  GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
• Z-2826-2026 · May 8, 2026 · Open, Classified
  Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative
• Z-2825-2026 · May 8, 2026 · Open, Classified
  Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative
• Z-2821-2026 · May 8, 2026 · Open, Classified
  Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment
• Z-2823-2026 · May 8, 2026 · Open, Classified
  Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative
• Z-2824-2026 · May 8, 2026 · Open, Classified
  Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative
• Z-1532-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055415004.
• Z-1524-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK, Part No. 00055360004.
• Z-1542-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055445008.
• Z-1525-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360008.
• Z-1529-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407508.
• Z-1537-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055430004.
• Z-1541-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055445004.
• Z-1543-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055445010 & 00055445011.
• Z-1538-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055430008.

…and 11 more.