Abbott Point Of Care Inc. Recall 87073
Description: 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
Abbott Point Of Care Inc. Recall 87073 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0880-2021 |
| Event ID | 87073 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 2,820,000 cartridges US and 2,273,453 catridges OUS |
| Recall Reason | 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. |
| Device Classification | 20210127 |
| Device Code Info | 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) |
| Center Classification Date | 20210119 |
| Recall Initiation Date | 20201222 |
| Recalling Firm | Abbott Point Of Care Inc. |
| Initial Notification | |
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