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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0880-2021
Event ID87073
Event DescriptionAbbott 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 TypeDevices
DistributionNationwide
Quantity2,820,000 cartridges US and 2,273,453 catridges OUS
Recall ReasonIonized 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 Classification20210127
Device Code InfoStored 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 Date20210119
Recall Initiation Date20201222
Recalling FirmAbbott Point Of Care Inc.
Initial Notification E-Mail
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