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Lower risk Medical device recall · FDA · Published May 21, 2026

Instrumentation Laboratory GEM Premier 5000 PAK: Lysing Bag Solution Risk

Instrumentation Laboratory recalls specific GEM Premier 5000 PAK models due to lysing bag solution concentration issues that may delay detection of blood abnormalities.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2900-2026Medical deviceInstrumentation Laboratory ›
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/314494-instrumentation-laboratory-gem-premier-5000-pak-lysing-bag-solution-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/314494-instrumentation-laboratory-gem-premier-5000-pak-lysing-bag-solution-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2900-2026

Cite this page

“Instrumentation Laboratory GEM Premier 5000 PAK: Lysing Bag Solution Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314494-instrumentation-laboratory-gem-premier-5000-pak-lysing-bag-solution-risk. Based on FDA recall #Z-2900-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2900-2026%22&limit=1).

The FDA announced on May 21, 2026, that Instrumentation Laboratory is recalling GEM Premier 5000 PAKs due to lysing bag solution concentration errors. This malfunction could delay the recognition of Co-Oximetry and total bilirubin abnormalities. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Instrumentation Laboratory
  • Product: GEM Premier 5000 PAK
  • Part Numbers: 00055360010, 00055360011, 00055407504, 00055415010, 00055430010, 00055430011, 00055445010
  • Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F
  • Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J
  • Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R
  • Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K
  • Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F
  • Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K
  • Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K
  • Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J
  • Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF

The hazard

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.

Context

GovInfoNow's records show Instrumentation Laboratory has 13 other recalls on record since 2021-08-25. Other recent recalls of similar products include GEM Premier 5000 Blood Analyzer (2026-05-08), GEM Premier 5000 PAK Cartridges (2026-01-20), and Instrumentation Laboratory Coagulation Test Kits (2025-12-11).

How to tell if you have this one

Check the product's part numbers: 00055360010, 00055360011, 00055407504, 00055415010, 00055430010, 00055430011, or 00055445010. Also look for lot numbers like 260505K, 260505F, or 260505J.

  • Brand
    Instrumentation Laboratory
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.
Recall numberProduct, codes & lotsQuantity
Z-2899-2026GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.; Part No.00077407508 UDI-DI 00195226000764 Lot 260504E; Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B; Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A; Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A; Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C; Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B32 units
Z-2900-2026GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A; Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;109 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Review the part numbers and lot numbers listed in the recall notice to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 15 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: May 21, 202612. FDA classified it Class II: Aug 6, 202623. Published in FDA’s Enforcement Report: Aug 12, 202634. Added to GovInfoNow: Aug 18, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-2900-2026 (May 21, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2900-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA