Use caution Medical device recall · FDA · Published September 29, 2023

Instrumentation Laboratory GEM Premier 3000 PAKs May Give False High pO2 Readings

Instrumentation Laboratory recalls GEM Premier 3000 PAKs with specific part numbers that may show false high oxygen levels in low ranges, risking delayed treatment of hypoxemia. Affected units include certain pH, pCO2, pO2, Hct, Na+, K+, Ca++ cartridges.

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

🇺🇸 FDA recall #Z-0358-2024Medical device Instrumentation Laboratory ›

Use caution until it’s fixed

Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.

Take action

Contact the company

Recalling firmInstrumentation Laboratory180 Hartwell Rd · Bedford, MA 01730-2443

✎ GovInfoNow plain-language explainer

Instrumentation Laboratory is recalling specific GEM Premier 3000 PAK cartridges that may show false high oxygen readings (pO2) at low levels. This could lead to delayed treatment of low oxygen conditions, which is serious for patients needing precise oxygen monitoring. Read more at govinfonow.com/recall/57194-instrumentation-laboratory-gem-premier-3000-paks-may-give-false-high.

Source Summary by GovInfoNow · govinfonow.com/recall/57194-instrumentation-laboratory-gem-premier-3000-paks-may-give-false-high · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0358-2024

Cite this page

“Instrumentation Laboratory GEM Premier 3000 PAKs May Give False High pO2 Readings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57194-instrumentation-laboratory-gem-premier-3000-paks-may-give-false-high. Based on FDA recall #Z-0358-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0358-2024%22&limit=1).

The FDA announced on Sept. 29, 2023, that Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to potential pO2 result errors. The agency said the devices may exhibit an over-recovery of oxygen levels in the low range.

How to tell if you have it

Brand: Instrumentation Laboratory
Product: GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++
Part Numbers: 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Lot Numbers: 323031H, 323531D, 324231M, 325031D, 324931F, 323831E, 323031I, 324231I, 324831E, 325631C (Part No. 00024307507); 323441B, 323641G, 323041H, 323541D, 324141J, 324841E, 325041D, 325641C (Part No. 00024315007); 323051H, 323551D, 323651G, 324151J (Part No. 00024330007); 323761H (Part No. 00024345007); 323771H, 323471B, 324871E (Part No. 00024360007)
Distribution: MA, MN, NY, India
Units affected: 2448

The hazard

Internal testing identified that the cartridges may exhibit an over-recovery of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications. The positive bias may lead to false positives for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.

Context

GovInfoNow's records show Instrumentation Laboratory has had 13 other recalls on record since Aug. 25, 2021. Other recent recalls of similar products include Abbott i-STAT EG6+ Cartridges May Show Wrong Blood Gas Results (April 1, 2026), NOxBOXi Nitric Oxide Delivery System: Potential for Irregular Oxygen Readings (Sept. 14, 2026), and Abbott i-STAT G3+ Cartridges May Show Wrong Blood Gas Results (April 1, 2026).

How to tell if you have this one

Check the part numbers on the PAKs: 00024307507, 00024315007, 00024330007, 00024345007, or 00024360007. Also look for specific lot numbers listed in the recall notice for each part number.

Brand
Instrumentation Laboratory
Category
Medical device

FDA recall event · 3 products

All 3 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
US States: MA, MN, NY. India.

Recall number	Product, codes & lots	Quantity
Z-0357-2024	GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004; Part No. 00024307504: UDI-DI: 08426950087922, Lot Numbers: 324230M, 323630G; Part No. 00024330004: UDI-DI: 08426950082507, Lot Numbers: 325655C, 322355C, 323755H, 323855E, 326255D; Part No. 00024345004: UDI-DI: 08426950082538, Lot Numbers: 325660C, 324160J, 323760H	2448 total
Z-0358-2024	GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007; Part No. 00024307507: UDI-DI: 08426950087946, Lot Numbers: 323031H, 323531D, 324231M, 325031D, 324931F, 323831E, 323031I, 324231I, 324831E, 325631C; Part No. 00024315007: UDI-DI: 08426950082484, Lot Numbers: 323441B, 323641G, 323041H, 323541D, 324141J, 324841E, 325041D, 325641C; Part No. 00024330007: UDI-DI: 08426950082514, Lot Numbers: 323051H, 323551D, 323651G, 324151J; Part No. 00024345007: UDI-DI: 08426950082545, Lot Numbers: 323761H; Part No. 00024360007: UDI-DI: 08426950082569, Lot Numbers: 323771H, 323471B, 324871E;	2448 units
Z-0359-2024	GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009; Part No. 00024315009: UDI-DI: 08426950082491, Lot Numbers: 323442F, 323142D, 323042K, 323142A, 323342K, 326142H, 323742C, 325442D, 325442E, 323042E, 324342A, 323042G, 323342H, 323542E, 324542A, 323542A, 324342B, 324042F, 323442H, 326442C, 325442F, 325942E, 326342B, 326142F, 325842C, 326442F; Part No. 00024330009: UDI-DI: 08426950082521, Lot Numbers: 323152A, 323152B, 324252B, 323552I, 323652I, 326152H, 323752B, 323352G, 323352H, 323052G, 323552A, 324352B, 324552A, 324052F, 323052E, 323352I, 323552F, 323352K, 325452F, 326352BC; Part No. 00024345009: UDI-DI: 08426950082552, Lot Numbers: 323462F, 323062K, 323162A, 323162C, 323562F, 323562I, 323662I, 323762D, 323762G, 323762J, 323862A, 323462C, 325762B, 323662D, 324462C, 324562A, 323362F, 325462F, 326362B; Part No. 00024360009: UDI-DI: 08426950082576, Lot Numbers: 323072J, 323072K, 323672I, 323772J, 324172D, 324372B, 323572A, 324072F, 325472F;	2448 units

Based on the official FDA remedy

What to do — step by step

Check PAK Part Numbers
Identify the part numbers on your GEM Premier 3000 PAKs to see if they match the recalled list: 00024307507, 00024315007, 00024330007, 00024345007, or 00024360007.
Verify Lot Numbers
Check the lot numbers for each part number against the specific lists provided in the recall notice to confirm if your unit is affected.

Where it went and when

Where it was distributed

Distributed in 3 states, and outside the U.S.

FDA distribution: “US States: MA, MN, NY. India.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Massachusetts, Minnesota, New York.

Recall timeline

FDA published this recall 2 months after the firm started it.

Sep 29, 2023Firm started the recall
Nov 20, 2023FDA classified it Class II
Nov 29, 2023Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/57194-instrumentation-laboratory-gem-premier-3000-paks-may-give-false-high">Instrumentation Laboratory GEM Premier 3000 PAKs May Give False High pO2 Readings (GovInfoNow)</a>

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-0358-2024 (September 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0358-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.