Recall Z-0357-2024 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
| Date | Nov 21, 2023 (initiated Sep 29, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 2448 total |
| Distribution | US States: MA, MN, NY. India. |
| FDA record | Open on fda.gov |