Reported Jan 27, 2021 · Terminated
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium,…
Abbott Point Of Care Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Point Of Care Inc. · 400 College Rd E · Princeton, NJ · 08540-6607
Is this the product you have?
- 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 Number03P88-25
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 lot numbers *20100 to *20339 7 days for 2 lot numbers *20340 and above Where * = 3 00054749000163lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163) - Amount recalled
- 2,820,000 cartridges US and 2,273,453 catridges OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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