Recall Z-1525-2026— Instrumentation Laboratory

Name: FDA recall Z-1525-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-20

Class II · Ongoing

Class II FDA medical device recall by Instrumentation Laboratory, initiated 2026-01-20. It names one FDA 510(k) clearance: K203790. Product: GEM Premier 5000 PAK; Part No. 00055360008.. Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact..

Recalling firm: Instrumentation Laboratory
Classification: Class II
Status: Ongoing
Initiated: 2026-01-20
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K203790 — GEM Premier 5000Instrumentation Laboratory CO·cleared 2021-08-20

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 5000 PAK; Part No. 00055360008.

Reason for recall

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

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