Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Brand
Instrumentation Laboratory
Lot Codes / Batch Numbers
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
Products Sold
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
Instrumentation Laboratory is recalling GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE RECALL notification letter dated 9/29/23 was sent to customers. Mandatory Customer Actions Please take the following immediate actions: " Check your inventory for the GEM Premier 3000 Non-iQM PAK (cartridge) lot numbers listed in Appendix A. " Discontinue use and destroy any GEM Premier 3000 Non-iQM PAK (cartridge) lot numbers listed in Appendix A. " Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to Werfen Regulatory at the fax number or e-mail address listed below. " Contact Werfen Customer Service at 1-800-955-9525 to order replacement PAKs (cartridges). " Share this information with your laboratory staff and follow your internal procedures. " Forward this notification to all affected locations within your facility. " Retain a copy of this notification for your records. Mandatory Response Tracking Record " Return the completed and signed Mandatory Response Tracking Form to: " Fax No.: 1-781-861-4207 Or " E-mail: ra-usa.na@werfen.com Contact Information for Questions " For technical questions, contact the Technical Support Center at 1-800-678-0710. " For replacement cartridges, contact Customer Service at 1-800-955-9525.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA, MN, NY
Page updated: Jan 10, 2026