9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and li...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1098-2021.
May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1098-2021.
Recall terminated by FDA.
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Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1098-2021.
Roche Diagnostics Operations, Inc.
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Roche Diagnostics Operations, Inc. Recall FAQ
Roche Diagnostics Operations, Inc. is the subject of a diagnostic devices safety report: 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and li.... The notice was published on January 6, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 1,214 units are potentially affected.