GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST 00055445010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08426950807810), received between Jun 21, 2022 and Aug 27, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient Data Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

23 other recalls cover devices cleared under the same FDA submission (K160225, K160402, K160415, K173403, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

   Z-2900-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Jan 20, 2026Class IIOpen, Classified

   Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

   Z-1543-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Patient Data Problem

  Following measurement of a sample associated with Patient ID (b)(6), a sample associated with Patient ID (b)(6) was subsequently measured. The user facility reported that when the barcode label for Patient ID (b)(6) was scanned, the system displayed the previously measured Patient ID (b)(6). The issue was reported to be associated with the GEM 5000 system barcode reader/scanner. As a result, measurement data were uploaded to an online record associated with a different patient's sample slot. There was no adverse patient impact associated with this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483267 ↗
• InjuryJun 21, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED A COMPLAINT INDICATING A GEM 5000 SENSOR AND REAGENT CARTRIDGE WAS RECEIVED WITH MOLD ON IT. THE CUSTOMER REPORTS UPON OPENING THE PACKAGING, MOLD WAS OBSERVED ON THE EXTERIOR OF THE CARTRIDGE CASE AND/OR LABELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753662 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160225, K160402, K160415, K173403, K203790. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-1534-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055415008.
• Z-1525-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360008.
• Z-1526-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360010.
• Z-1538-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055430008.
• Z-1532-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055415004.
• Z-1527-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360011.
• Z-1530-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407510.
• Z-1533-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055415005.
• Z-1529-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407508.
• Z-1528-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407504.

…and 8 more.