Abbott Point Of Care Inc.: Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capill

Is my product affected?

Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25

• UPC 00054749000163

Check against the official notice below — it lists the full affected range.

What happened

Abbott Point of Care Inc. is recalling Abbott i-STAT EG7+ cartridges used to measure sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in blood samples. The ionized calcium test results on some cartridges may show higher than expected values when the cartridges are stored at room temperature (18 to 30°C) for more than 3 days for lot numbers *20100 to *20339, or more than 7 days for lot numbers *20340 and above, where the asterisk represents lot letters A, K, L, M, N, W or Y. The recall affects 1,521,800 cartridges in the US and 2,641,053 cartridges outside the US.

The recall was distributed nationwide. The source document does not specify what consumers or healthcare providers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide Quantity: 1,521,800 cartridges US and 2,641,053 cartridges OUS Lot/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)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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