Instrumentation Laboratory is recalling approximately 9,477 GEM Premier 5000 PAK cartridges due to a defect where the system may not detect the internal process control solution during warm-up. This error can lead to the cartridge being ejected and requiring the insertion of a new one, which can happen multiple times in a row. These cartridges are used in medical laboratory settings for critical blood testing, and the recall affects various part numbers and lot codes manufactured in the United States. If a cartridge successfully completes its validation after warm-up, it can still be used, but consecutive ejections may significantly delay patient test results.
The repeated ejection of testing cartridges during the warm-up phase can delay critical test results, potentially affecting patient management decisions. While the built-in quality control program (iQM2) ensures that any cartridge that passes validation is safe to use, the disruption caused by consecutive failures may impact laboratory operations and timely care.
Recall #: Z-1524-2026; Quantity: 51 units
Recall #: Z-1525-2026; Quantity: 30 units
Recall #: Z-1526-2026; Quantity: 1,225 units
Recall #: Z-1527-2026; Quantity: 10 units
Recall #: Z-1528-2026; Quantity: 489 units
Recall #: Z-1529-2026; Quantity: 180 units
Recall #: Z-1530-2026; Quantity: 1,126 units
Recall #: Z-1531-2026; Quantity: 27 units
Recall #: Z-1532-2026; Quantity: 352 units
Recall #: Z-1533-2026; Quantity: 8 units
Recall #: Z-1534-2026; Quantity: 195 units
Recall #: Z-1535-2026; Quantity: 1,629 units
Recall #: Z-1536-2026; Quantity: 7 units
Recall #: Z-1537-2026; Quantity: 253 units
Recall #: Z-1538-2026; Quantity: 74 units
Recall #: Z-1539-2026; Quantity: 1,607 units
Recall #: Z-1540-2026; Quantity: 25 units
Recall #: Z-1541-2026; Quantity: 130 units
Recall #: Z-1542-2026; Quantity: 70 units
Recall #: Z-1543-2026; Quantity: 1,989 units (combined with 00055445011)
Recall #: Z-1543-2026; Kits distributed in US: 96
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.