Instrumentation Laboratory recalls specific GEM Premier 5000 PAK models due to lysing bag solution concentration issues that may delay detection of blood abnormalities.
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.
Instrumentation Laboratory is recalling specific GEM Premier 5000 PAK models because the lysing bag solution may not work properly. This could lead to delayed detection of blood abnormalities like low oxygen levels or high bilirubin, which are serious health issues.
The lysing bag solution in specific batches has lower active ingredient concentration than intended. This can cause blood tests to show inaccurate results, potentially delaying treatment for conditions like low oxygen levels or high bilirubin in blood.
Healthcare professionals using the GEM Premier 5000 PAK for blood tests may be affected. Patients with blood conditions requiring frequent monitoring are at higher risk.
Check the product's part numbers: 00055360010, 00055360011, 00055407504, 00055415010, 00055430010, 00055430011, or 00055445010. Also look for lot numbers like 260505K, 260505F, or 260505J.
Review the part numbers and lot numbers listed in the recall notice to confirm if your device is affected.
The lysing bag solution in specific batches has lower active ingredient concentration than intended, which may cause blood tests to show inaccurate results.
Using the affected product may delay detection of blood abnormalities like low oxygen levels or high bilirubin, which can lead to serious health issues if untreated.
Check the part numbers: 00055360010, 00055360011, 00055407504, 00055415010, 00055430010, 00055430011, or 00055445010. Also look for lot numbers like 260505K, 260505F, or 260505J.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-2900-2026 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-2900-2026 from Instrumentation Laboratory. 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.
