Sterling Diagnostics Recalls Creatinine Diagnostic Kits Due to Expiration Date Error
Sterling Diagnostics is recalling 182 units of Creatinine/Endpoint diagnostic kits because previously extended expiration dates were rescinded.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 indicates a low risk of adverse health consequences. The issue is a documentation/labeling error regarding expiration dates rather than a direct safety hazard like contamination or malfunction.
Plain-English summary
Sterling Diagnostics, Inc. initiated a recall on July 20, 2016, for 182 units of Creatinine/Endpoint [Modified Heinegard-Tiderstrom] diagnostic kits. These kits are used for in vitro diagnostic purposes to quantitatively determine analytes. The specific lot number is 16751, with a catalog number of 2167-O. The products were manufactured on June 2, 2015, and have an expiration date of May 2018.
The recall was initiated due to the rescission of previously extended expiration dates for the kits. This means the expiration dates originally provided to customers were changed, necessitating the recall of the affected units.
The affected products 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 specific kits and contact Sterling Diagnostics for further instructions or replacement.
The recalled product
- Product
- Creatinine/Endpoint [Modified Heinegard-Tiderstrom] 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
- 182
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)
- Creatinine/Endpoint [Modified Heinegard-Tiderstrom]
- CAT No. 2167-O
- Lot No. 16751
- Expriry: 5/18
- Manufactured: 06/02/15
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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