Summary
The FDA issued a Class II for GEM Premier 5000 PAK, Part No. 00055360004. by Instrumentation Laboratory. Reason: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control.
Details
Source
Device Recall
External ID
Z-1524-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
GEM Premier 5000 PAK, Part No. 00055360004.
Lot/Code Info: Part number: 00055360004; UDI: 08426950899662; Lot No. 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X.
Quantity Affected: 51 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-20
Company
Bedford, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Instrumentation Laboratory) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Instrumentation Laboratory have FDA actions?
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1524-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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