GEM recalls specific GEM Premier 5000 cartridges that may cause repeated process errors during warm-up, leading to ejections and delays in test results. Affected units include certain lot numbers and part numbers.
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.
GEM is recalling specific cartridges for the GEM Premier 5000 blood analyzer that can cause repeated errors during warm-up, potentially leading to test delays. This issue may require inserting new cartridges more often than usual, but it does not pose an immediate safety risk.
The cartridges may cause repeated errors during warm-up, leading to the analyzer ejecting the cartridge and requiring a new one. This can prolong test turnaround times and potentially delay patient results if the issue occurs multiple times in a row.
Laboratories using the GEM Premier 5000 blood analyzer with the affected cartridges (part numbers 00055430008 and specific lot numbers) are most at risk. Patients may experience delays in test results if the analyzer requires repeated cartridge replacements.
Check for part number 00055430008 on the cartridge. Affected lots include 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X, and 251230P.
Verify the lot number on the cartridge to see if it matches the affected lots listed: 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X, or 251230P.
No, the recall does not require stopping use. Laboratories can continue using the analyzer with unaffected cartridges.
The analyzer may eject the cartridge and require a new one, which can delay test results. This may happen multiple times during warm-up.
Check the part number (00055430008) and lot number against the listed affected lots: 251106X, 251110AF, 251202P, 251203Q, 251215J, 251229AG, 251229X, or 251230P.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1538-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1538-2026 from GEM. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
