GEM Premier 5000; Part No. 00055445008.
Pending LLM rewrite. Source: FDA_DEVICE Z-1542-2026.
- Product
- GEM Premier 5000; Part No. 00055445008.
- Category
- Medical Device
- Distribution
- Distributed nationwide
Manufacturer
38 recalls in our database name Instrumentation Laboratory as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Pending LLM rewrite. Source: FDA_DEVICE Z-1542-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1539-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1524-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1528-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1532-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1525-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1534-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1535-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1531-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1540-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1529-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1530-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1538-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1526-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1541-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1533-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1543-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1527-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1536-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1537-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1095-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0938-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-2323-2025.
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to a defect that can produce falsely high blood oxygen readings. The inaccuracy may prevent detection of dangerously low oxygen levels and delay necessary treatment.