GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST 00055430010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08426950807759), received between Aug 13, 2026 and Sep 25, 2026 — classified as 3 deaths.

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-1539-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, the customer reported receiving incalculable results on a GEM 5000 analyzer and expressed concern that it was unclear whether the reported result was due to failed iQM2 quality checks or analyte values falling outside the analyzer's reportable range. The customer stated that this lack of clarity could impact clinical interpretation and decision-making. Due to uncertainty regarding the meaning of the result, the sample was repeated on a second analyzer, which reportedly produced similar findings. The customer requested clarification regarding the analyzer's reporting logic, specifically when results are displayed with less-than or greater-than reportable range indicators ("<" or ">") versus being reported as "incalculable."To further assess the patient, the customer performed a finger-stick glucose test, which reportedly indicated a glucose value below the reportable range. Based on this result, clinical intervention was initiated. Approximately 20 minutes later, a repeat blood gas sample was analyzed. The customer reported that the patient subsequently expired.The customer expressed concern that the patient's extremely low glucose concentration may have been reporte

  Patient problems: Insufficient Information

  MAUDE report 50898447 ↗
• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, the customer reported receiving incalculable results on a GEM 5000 analyzer and expressed concern that it was unclear whether the reported result was due to failed iQM2 quality checks or analyte values falling outside the analyzer's reportable range. The customer stated that this lack of clarity could impact clinical interpretation and decision-making. Due to uncertainty regarding the meaning of the result, the sample was repeated on a second analyzer, which reportedly produced similar findings. The customer requested clarification regarding the analyzer's reporting logic, specifically when results are displayed with less-than or greater-than reportable range indicators ("<" or ">") versus being reported as "incalculable."To further assess the patient, the customer performed a finger-stick glucose test, which reportedly indicated a glucose value below the reportable range. Based on this result, clinical intervention was initiated. Approximately 20 minutes later, a repeat blood gas sample was analyzed. The customer reported that the patient subsequently expired.The customer expressed concern that the patient's extremely low glucose concentration may have been reporte

  Patient problems: Insufficient Information

  MAUDE report 50898442 ↗
• DeathAug 13, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, the customer reported a delay in obtaining lactate testing results on a GEM 5000 analyzer located in the he Emergency Department. The customer stated that a patient death had occured follwoing a delay in obtaining lactate results, as lactate could not be measured in the ER and testing had to be delayed until the patient reached the ICU.

  Patient problems: Insufficient Information

  MAUDE report 50236251 ↗

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-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-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-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-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-1525-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360008.
• Z-1531-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407511.
• Z-1541-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055445004.
• Z-1542-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055445008.
• Z-1533-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055415005.
• Z-1540-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No. 00055430011.
• Z-1536-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000; Part No: 00055415011.
• Z-1527-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055360011.
• Z-1524-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK, Part No. 00055360004.
• Z-1528-2026 · Jan 20, 2026 · Open, Classified
  GEM Premier 5000 PAK; Part No. 00055407504.

…and 8 more.