Sterling Diagnostics Recalls HDL Cholesterol Kits Due to Expiration Date Error
Sterling Diagnostics is recalling HDL Cholesterol diagnostic kits because previously extended expiration dates were rescinded.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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The hazard is a labeling/documentation error regarding expiration dates, fitting the criteria for a moderate severity score.
Plain-English summary
Sterling Diagnostics, Inc. initiated a recall on July 20, 2016, for multiple diagnostic kits. The specific product identified is the HDL Cholesterol (PEF Method) kit, intended for in vitro diagnostic use in the quantitative determination of analytes.
The recall was initiated due to the rescission of previously extended expiration dates for the kits. The affected units are identified by Catalog No. 2150-P, Lot No. 15051, with an expiration date of 3/18 and a manufacture date of 03/10/15. A total of 245 units were distributed domestically to Michigan and internationally to the Philippines.
No illnesses or injuries have been reported in connection with this recall. Consumers and healthcare facilities should stop using the affected kits and contact Sterling Diagnostics, Inc. for further instructions or replacement.
The recalled product
- Product
- Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) 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
- 245
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)
- HDL Cholesterol
- CAT No. 2150-P
- Lot No. 15051
- Expriry: 3/18
- Manufactured: 03/10/15
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
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