Instrumentation Laboratory recalls GEM Premier 5000 PAK, Part No. 00055360004.
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…
Read the official notice →- Date
- 2026-03-18
- Country
- United States
- Brand
- Instrumentation Laboratory
- Product
- GEM Premier 5000 PAK, Part No. 00055360004.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Argentina,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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