Abbott ICT Serum Calibrator Recalled for Inaccurate Potassium Results
Abbott Laboratories is recalling ICT Serum Calibrator REF 146-03 because it may generate lower than expected Potassium results on the Abbott Architect cSystem.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of inaccurate diagnostic results (lower than expected Potassium) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Laboratories is recalling 11,215 units of ICT Serum Calibrator REF 146-03. This product is used for the calibration of serum Sodium, Potassium, and Chloride assays. The recall is due to the potential for the calibrator to generate lower than expected Potassium Quality Control (QC) and patient results when used with the Abbott Architect cSystem.
The affected lot numbers are 21399UN13, 67873UN13, 74710UN13, 82008UN13, and 88884UN13. These lots have expiration dates ranging from August 5, 2014, to February 4, 2015. The product was distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous international countries.
Healthcare facilities and laboratories should stop using the affected calibrator and contact Abbott Laboratories for further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
- Manufacturer
- Abbott Laboratories
- Hazard
- Affected units
- 11,215
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot numbers: 21399UN13 (Expiration date: 5AUG2014)
- 67873UN13 (Expiration date: 12NOV2014)
- 74710UN13 (Expiration date: 8DEC2014)
- 82008UN13 (Expiration date: 14JAN2015)
- 88884UN13 (Expiration date: 4FEB2015)
Distribution
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