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.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Instrumentation Laboratory or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Get instant alerts for Instrumentation Laboratory recalls
Be the first to know. Free instant alerts to your inbox.
GEM Premier 5000 PAK; Part No. 00055360011.. 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.. Classification: Class II. Quantity: 10 units. 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.
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsGet instant alerts for recalls that affect you. Free forever.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Rising Pharmaceuticals recalls 1,200 Temozolomide 5 mg capsules nationwide after a stability test found out-of-spec impurities. The drug is Rx-only, with NDC 16571-816-51 and lot 1TM0524003A. Stop using immediately and contact a healthcare provider for guidance.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Kirkman recalled 178 bottles of MAXIMUM Zone 1 4% Lidocaine Cream distributed nationwide in the U.S. by Dermal Source. The recall cites stability data that does not support the stated expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.
HTO Nevada Inc. dba Kirkman recalled 243 bottles of MAXIMUM ZONE 2, 4% lidocaine cream distributed nationwide by Dermal Source. The recall cites stability data that does not support an expiry date. Consumers and healthcare providers should stop using this product immediately and contact Kirkman for guidance.
Cipla USA recalls 271 cartons of Nilotinib 150 mg capsules nationwide after stability tests show out-of-spec results. The issue affects description and appearance by visual inspection. Stop using and contact Cipla USA or a clinician for guidance.
HTO Nevada Inc. dba Kirkman recalls 27,380 bottles of FIVE-STAR VASOCAINE Spray distributed nationwide by Dermal Source. The recall cites stability data that does not support the product's expiry date. Stop using the spray and contact Kirkman or your healthcare provider for guidance.
Nilotinib capsules manufactured for Cipla USA are recalled nationwide after stability testing showed out-of-spec results. The failure involves description and appearance by visual inspection at six months of long-term stability. Patients and healthcare providers should stop using the product immediately and contact Cipla USA for guidance.