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

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 indicate 2448 total units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices and 1 involve the same firm, Instrumentation Laboratory. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.