Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
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 m…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Instrumentation Laboratory recalled GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 0002434… - a moderate-severity action.
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 0002434… was recalled by Instrumentation Laboratory in November 29, 2023. Reason: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positi…. Check the official notice for the remedy. Verify recall #Z-0357-2024 with the FDA Devices before acting.
The recall
Instrumentation Laboratory issued this moderate-severity FDA Devices recall-Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positi….
- Moderate
- severity level
- Class II
- classification
- November 29, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0357-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0357-2024) was formally reported on November 29, 2023, with the manufacturer initiating the action on September 29, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Instrumentation Laboratory is listed as the recalling firm, operating out of Bedford, MA. Federal records list the affected scope as 2448 total.
The documented reason for this recall is: 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 perform… Distribution data in the federal record shows the product reached: US States: MA, MN, NY. India.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2448 total
Related Recalls
6
3 from same agency
Product description
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0357-2024 |
| Date reported | November 29, 2023 |
| Date initiated | September 29, 2023 |
| Recalling firm | Instrumentation Laboratory |
| Firm location | Bedford, MA |
| Affected scope | 2448 total |
| Distribution | US States: MA, MN, NY. India. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0357-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004. Recalled by Instrumentation Laboratory. Units affected: 2448 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0357-2024.
Where was the recalled product distributed? ▼
Distribution: US States: MA, MN, NY. India..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0357-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 29, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.