Sterling Diagnostics Recalls Enzymatic Uric Acid Diagnostic Kits
Sterling Diagnostics is recalling 173 Enzymatic Uric Acid diagnostic kits because previously extended expiration dates were rescinded.
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 by definition is unlikely to cause adverse health consequences. The issue is administrative (rescinded expiration dates) rather than a physical defect or contamination.
Plain-English summary
Sterling Diagnostics, Inc. initiated a recall on July 20, 2016, for 173 units of Enzymatic Uric Acid (Uricase Trinder) diagnostic kits. These products are intended for in vitro diagnostic use in the quantitative determination of analytes and are classified as consumables.
The recall was initiated due to the rescission of previously extended expiration dates for the kits. The specific lot number is 30551, with an expiration date of 7/18 and a manufacture date of 07/21/15. The product code is Urea Nitrogen/Color BUN, CAT No. 2305-O.
The affected units were distributed domestically in Michigan and internationally to the Philippines. There is no distribution to VA/DOD facilities. Consumers and healthcare facilities should stop using these kits and contact Sterling Diagnostics for further instructions.
The recalled product
- Product
- Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) 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
- 173
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. 2305-O
- Lot No. 30551
- Expriry: 7/18
- Manufactured: 07/21/15
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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