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GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST 00055430011Recalls & reported problems

Instrumentation Laboratory Company · GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

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

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-1540-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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-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-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-1536-2026 · Jan 20, 2026 · Open, Classified
    GEM Premier 5000; Part No: 00055415011.
  • Z-1538-2026 · Jan 20, 2026 · Open, Classified
    GEM Premier 5000; Part No. 00055430008.
  • Z-1531-2026 · Jan 20, 2026 · Open, Classified
    GEM Premier 5000 PAK; Part No. 00055407511.
  • Z-1539-2026 · Jan 20, 2026 · Open, Classified
    GEM Premier 5000; Model No. 00055430010.
  • Z-1530-2026 · Jan 20, 2026 · Open, Classified
    GEM Premier 5000 PAK; Part No. 00055407510.
  • Z-1527-2026 · Jan 20, 2026 · Open, Classified
    GEM Premier 5000 PAK; Part No. 00055360011.
  • 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-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.

…and 8 more.

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Sources and updates

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