Sterling Diagnostics Recalls Colorimetric SGOT Kits Due to Expiration Date Error
Sterling Diagnostics is recalling 165 Colorimetric SGOT diagnostic kits because previously extended expiration dates were rescinded.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, and the issue is a documentation/labeling error regarding expiration dates.
Plain-English summary
Sterling Diagnostics, Inc. initiated a recall on July 20, 2016, for 165 units of Colorimetric SGOT diagnostic kits. The recall was triggered by the rescission of previously extended expiration dates for these kits.
The affected product is identified by Catalog No. 2250-O, Lot No. 20051, with an expiration date of January 2019 and a manufacture date of January 11, 2016. These kits are intended for in vitro diagnostic use in the quantitative determination of analytes.
The product was distributed domestically in Michigan and internationally to the Philippines. No distribution to VA/DOD facilities is reported. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- Sterling Diagnostics, Inc.Colorimetric SGOT 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
- 165
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)
- Colorimetric SGOT
- CAT No. 2250-O
- Lot No. 20051
- Expriry: 1/19
- Manufactured: 01/11/16
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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