Instrumentation Laboratory — Class II: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 000240
Instrumentation Laboratory has initiated a Class II recall for the GEM Premier 5000 and 7000 systems due to an issue where Bar Code Reader (BCR) wands may incorrectly assign patient results to the wrong patient ID.
This affects clinical laboratories, hospitals, and point-of-care facilities using the GEM Premier 5000 (Model 00024019255) and GEM Premier 7000 portable blood analyzer systems.
Incorrect patient identification poses a risk of diagnostic errors and improper treatment decisions. From a regulatory perspective, this suggests a failure in the peripheral device's ability to maintain data integrity throughout the diagnostic workflow, likely requiring a field correction or software update to mitigate the risk of patient misidentification.
Verification of barcode scanner performance and patient ID mapping workflows is advised for users of these systems. QA teams should evaluate if this issue necessitates updated user training or software patches to ensure data integrity between the device and patient records.
Class II. Reason: Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.. Product: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system. Firm: Instrumentation Laboratory (Bedford MA United States). Status: Ongoing.
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