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GEM Premier 5000 PAK
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MEDICAL DEVICE RECALLMODERATE

GEM Premier 5000 PAK

Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to errors that may cause ejection and delay patient results.

What to do

If a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Monitor for consecutive ejections and plan for potential operational disruptions to minimize impact on testing turnaround times.

Recalled
Listed
Updated
Recall No.
Z-1524-2026
Agency
FDA
Firm
Instrumentation Laboratory
Recall ID
98349
Status
ONGOING

Why it was recalled

Instrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up. These errors can cause consecutive cartridge ejections, which may prolong turnaround times and potentially delay critical patient results. The affected product is distributed nationwide.

Is mine affected?

This recall covers 20 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
GEM Premier 5000; Part No. 00055415005.Z-1533-202600055415005, 08426950807667
GEM Premier 5000 PAK, Part No. 00055360004.Z-1524-202600055360004, 08426950899662
GEM Premier 5000; Part No. 00055415008.Z-1534-202600055415008, 08426950807674
GEM Premier 5000; Part No. 00055430008.Z-1538-202600055430008, 08426950807735
GEM Premier 5000 PAK; Part No. 00055407511.Z-1531-202600055407511, 08426950807643
GEM Premier 5000; Model No. 00055430010.Z-1539-202600055430010, 08426950807759
GEM Premier 5000; Part No. 00055445008.Z-1542-202600055445008, 08426950807797
GEM Premier 5000 PAK; Part No. 00055360011.Z-1527-202600055360011, 08426950807605
Show all 20 products
ProductRecall #UDI-DI
GEM Premier 5000 PAK; Part No. 00055407510.Z-1530-202600055407510, 08426950807636
GEM Premier 5000 PAK; Part No. 00055407508.Z-1529-202600055407508, 08426950807612
GEM Premier 5000; Part No. 00055430004.Z-1537-202600055430004, 08426950807711
GEM Premier 5000; Part No: 00055415011.Z-1536-202600055415011, 08426950807704
GEM Premier 5000; Part No. 00055430011.Z-1540-202600055430011, 08426950807766
GEM Premier 5000 PAK; Part No. 00055415004.Z-1532-202600055415004, 08426950807650
GEM Premier 5000; Part No. 00055445010 & 00055445011.Z-1543-202600055445010, 08426950807810, 00055445011, 08426950807827
GEM Premier 5000 PAK; Part No. 00055360010.Z-1526-202600055360010, 08426950807599
GEM Premier 5000 PAK; Part No. 00055407504.Z-1528-202600055407504, 08426950807537
GEM Premier 5000 PAK; Part No. 00055360008.Z-1525-202600055360008, 08426950807575
GEM Premier 5000; Part No. 00055415010.Z-1535-202600055415010, 08426950807698
GEM Premier 5000; Part No. 00055445004.Z-1541-202600055445004, 08426950807773

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Instrumentation Laboratory

All recalls from Instrumentation Laboratory

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Editorial summary by Recall Canary · summary updated 2026-07-18 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification