Ortho-Clinical VITROS Potassium Slides Recalled for Unintentional Surfactant Addition
Ortho-Clinical Diagnostics is recalling VITROS Potassium Slides because a surfactant was unintentionally added during manufacturing.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which by definition indicates a low probability of adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596. The recall was initiated after the manufacturer determined during interval testing that a surfactant was unintentionally added to the product during the manufacturing process.
The affected product is intended for in vitro diagnostic use only to quantitatively measure potassium concentration in serum, plasma, and urine. The recall covers 236,364 units distributed domestically and 8,339 units distributed internationally. Distribution included the United States (including Puerto Rico) and various countries worldwide.
The specific affected lots are identified by GEN 4102, Coating 0884, and GEN 4102, Coating 0885, with expiration dates of 06/01/2014 and 07/01/2014. Users should check their inventory for these specific lot codes and stop using the affected slides.
The recalled product
- Product
- VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS…
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 (4)
- GEN 4102
- Coating 0884
- Lot XXXX (exp. 06/01/2014) and GEN 4102
- Coating 0885
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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