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Sterling Diagnostics is recalling 131 Urea Nitrogen diagnostic kits because previously extended expiration dates were rescinded.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.
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 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 The recall was necessary because the company rescinded previously extended expiration dates for these kits.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.
See all 9 products in this recall →Related recalls
Same manufacturer · Sterling Diagnostics, Inc.
See all →- LowSterling Diagnostics Recalls Enzymatic Glucose Diagnostic Kits
FDA (Devices) · 2017-01-04
- LowSterling Diagnostics Recalls Enzymatic Cholesterol Diagnostic Kits
FDA (Devices) · 2017-01-04
- LowSterling Diagnostics Recalls Enzymatic Uric Acid Diagnostic Kits
FDA (Devices) · 2017-01-04
- LowSterling Diagnostics Recalls Creatinine Diagnostic Kits Due to Expiration Date Error
FDA (Devices) · 2017-01-04
- LowSterling Diagnostics Recalls Colorimetric SGOT Kits Due to Expiration Date Error
FDA (Devices) · 2017-01-04
Same hazard · mis labeling
See all →- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
Similar recalls
- ModerateAMS BUN Urea Nitrogen Kits Recalled for Marketing Violations
FDA (Devices) · 2014-04-02
- ModerateSiemens Recalls Dimension Vista BUN Reagent Cartridges for Inaccurate Results
FDA (Devices) · 2016-05-18
- LowBBL CrystaLEAD E/NF Identification Kits Recalled for Incorrect Expiration Dates
FDA (Devices) · 2014-07-23
- ModerateOrtho Clinical Diagnostics Recalls Urine Electrolyte Diluent Due to Instability
FDA (Devices) · 2020-01-01
- LowBiomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date
FDA (Devices) · 2014-11-26
- LowBiomerieux Recalls Etest Ceftaroline Devices Due to Incorrect Expiration Date Labeling
FDA (Devices) · 2014-11-26