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Z-1527-2026 Class II Ongoing

Recalled by Instrumentation Laboratory — Bedford, MA

FDA device recall Z-1527-2026 was initiated by Instrumentation Laboratory on January 20, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 10 units.

Recall Details

Product Type: Devices
Report Date: March 18, 2026
Initiation Date: January 20, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10 units

Product Description

GEM Premier 5000 PAK; Part No. 00055360011.

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.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macau, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, San Marino, South Africa, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan & Vietnam.

Code Information

Part number: 00055360011; UDI: 08426950807605; Lots No.: 251119A.

Other recalls by Instrumentation Laboratory

Z-1535-2026 Class II — GEM Premier 5000; Part No. 00055415010. (January 20, 2026)
Z-1537-2026 Class II — GEM Premier 5000; Part No. 00055430004. (January 20, 2026)
Z-1526-2026 Class II — GEM Premier 5000 PAK; Part No. 00055360010. (January 20, 2026)
Z-1541-2026 Class II — GEM Premier 5000; Part No. 00055445004. (January 20, 2026)
Z-1530-2026 Class II — GEM Premier 5000 PAK; Part No. 00055407510. (January 20, 2026)
Z-1538-2026 Class II — GEM Premier 5000; Part No. 00055430008. (January 20, 2026)
Z-1540-2026 Class II — GEM Premier 5000; Part No. 00055430011. (January 20, 2026)
Z-1524-2026 Class II — GEM Premier 5000 PAK, Part No. 00055360004. (January 20, 2026)
Z-1532-2026 Class II — GEM Premier 5000 PAK; Part No. 00055415004. (January 20, 2026)
Z-1533-2026 Class II — GEM Premier 5000; Part No. 00055415005. (January 20, 2026)