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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93313

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 29, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Instrumentation Laboratory

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004

Z-0357-2024
Recall number
Z-0357-2024
Initiated
September 29, 2023
Classification
Class II
Status
Ongoing
Quantity
2448 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

US States: MA, MN, NY. India.

device · product 2 of 3

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007

Z-0358-2024
Recall number
Z-0358-2024
Initiated
September 29, 2023
Classification
Class II
Status
Ongoing
Quantity
2448 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

Distribution pattern

US States: MA, MN, NY. India.

device · product 3 of 3

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009

Z-0359-2024
Recall number
Z-0359-2024
Initiated
September 29, 2023
Classification
Class II
Status
Ongoing
Quantity
2448 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

Distribution pattern

US States: MA, MN, NY. India.