Sterling Diagnostics Recalls Enzymatic Cholesterol Diagnostic Kits
Sterling Diagnostics is recalling 97 units of Enzymatic Cholesterol diagnostic kits due to a revision of previously extended expiration dates.
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 by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling correction regarding expiration dates, with no reported injuries or illnesses.
Plain-English summary
Sterling Diagnostics, Inc. initiated a recall on July 20, 2016, for 97 units of Enzymatic Cholesterol (Trinder/COD-CEH) 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 a revision of the previously extended expiration dates for the kits. The specific product details include Catalog No. 2145-L, Lot No. 14551, with an expiration date of 11/18 and a manufacture date of 11/04/15.
The affected units were distributed domestically in Michigan and internationally to the Philippines. No distribution to VA/DOD facilities is reported. The source text does not specify any reported illnesses, injuries, or adverse health consequences associated with the use of these kits.
The recalled product
- Product
- Enzymatic Cholesterol (Trinder/COD-CEH) 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
- 97
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)
- Cholesterol
- CAT No. 2145-L
- Lot No. 14551
- Expiry: 11/18
- Manufactured: 11/04/15
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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