FDAFDA · Food and drugs·Recall number Z-0880-2021
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25
Published January 27, 2021 · Recall initiated: December 22, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Abbott Point Of Care Inc.
- Distributor
- Nationwide
- Lot
- Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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