Sterling Diagnostics Recalls Urea Nitrogen Diagnostic Kits Due to Expiration Date Error
Sterling Diagnostics is recalling 131 Urea Nitrogen diagnostic kits because previously extended expiration dates were rescinded. The kits were distributed in Michigan and the Philippines.
What this means for you
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates.
Plain-English summary
Sterling Diagnostics, Inc. initiated a recall on July 20, 2016, for 131 units of Urea Nitrogen/Color BUN (Enzymatic Berthelot) diagnostic kits. The recall was necessary because the company rescinded previously extended expiration dates for these kits. The affected product is identified by Catalog No. 2290-L, Lot No. 29051, with an expiration date of 9/18 and a manufacture date of 09/21/15.
The recalled kits are intended for in vitro diagnostic use in the quantitative determination of analytes. They are classified as consumables, meaning customers purchase replacements when the kit is consumed. The distribution pattern indicates the products were shipped domestically to Michigan and internationally to the Philippines. No distribution to VA/DOD facilities was reported.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Consumers and healthcare facilities should stop using the affected lots and contact Sterling Diagnostics for instructions on return or disposal.
The recalled product
- Product
- Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Manufacturer
- Sterling Diagnostics, Inc.
- Hazard
- Affected units
- 131
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)
- Urea Nitrogen/Color BUN
- CAT No. 2290-L
- Lot No. 29051
- Expriry: 9/18
- Manufactured: 09/21/15
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 9 recalled by Sterling Diagnostics, Inc. 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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