Recall Z-0358-2024— Instrumentation Laboratory

Name: FDA recall Z-0358-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-29

Class II · Ongoing

Class II FDA medical device recall by Instrumentation Laboratory, initiated 2023-09-29. It names 2 FDA 510(k) clearances: K161818, K992834. Product: GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007. 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..

Recalling firm: Instrumentation Laboratory
Classification: Class II
Status: Ongoing
Initiated: 2023-09-29
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K161818 — GEM Premier 3000Instrumentation Laboratory CO·cleared 2016-09-14
K992834 — GEM PREMIER 3000Instrumentation Laboratory CO·cleared 1999-11-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.