AMS Diagnostics Recalls Medica ISE Module Calibrant A Due to Physical Defects
AMS Diagnostics is recalling 9 units of Medica ISE Module Calibrant A because the lot was not functioning properly and did not exhibit correct physical properties.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The defect is a functional/physical property issue with a calibrant, not a direct patient safety hazard like a contaminated drug or device.
Plain-English summary
AMS Diagnostics, LLC is voluntarily recalling 9 units of Medica ISE Module Calibrant A. The product is a 500 mL calibrant solution containing 140 mmol/L Na+, 125 mmol/L Cl-, buffers, and preservatives, intended for use with the ISE Module for integrated electrolyte system analysis.
The recall was initiated because the specific lot was not functioning properly and was not exhibiting the correct physical properties. The affected product is identified by Product Number 5409, Lot Number 15251, and an expiration date of 09/2016.
The recalled units were distributed nationwide in the United States, specifically in the states of Arizona, California, Florida, Michigan, North Carolina, New York, and South Carolina. Consumers and healthcare facilities should stop using the product and contact AMS Diagnostics for instructions on return or disposal.
The recalled product
- Product
- Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
- Manufacturer
- AMS Diagnostics, LLC
- Hazard
- Affected units
- 9
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 (3)
- P/N 5409
- Lot No. 15251
- Exp. Date 09/2016
Distribution
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