Trademark Blood Gas/Electrolyte/Glucose, Lactate, Bun and Creatinine Control

• 2 recalls, same reason

  • Ongoing Z-1314-2024 FDA Class II ·initiated 9 Jan 2024
  • Ongoing Z-1315-2024 FDA Class II ·initiated 9 Jan 2024

  Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

510(k) Number

K972868 ↗

FDA Product Code

JJY

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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