Sterling Diagnostics Recalls SGPT Colorimetric Kits Due to Expiration Date Error
Sterling Diagnostics is recalling SGPT Colorimetric kits because previously extended expiration dates were rescinded.
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 error regarding expiration dates rather than a physical defect or contamination.
Plain-English summary
Sterling Diagnostics, Inc. initiated a recall on July 20, 2016, for multiple SGPT Colorimetric diagnostic kits. The recall was initiated due to the rescission of previously extended expiration dates for these kits.
The affected product is the SGPT Colorimetric kit, intended for in vitro diagnostic use in the quantitative determination of analytes. The specific lot number is 26051, with a catalog number of 2260-0. The kits were manufactured on April 27, 2015, and have an expiration date of April 2018.
The recall covers 51 units. Distribution was domestic to Michigan and foreign to the Philippines. No VA/DOD distribution is reported. Consumers and healthcare facilities should stop using the affected kits and contact Sterling Diagnostics for further instructions.
The recalled product
- Product
- Sterling Diagnostics, Inc., SGPT Colorimetric 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
- 51
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)
- SGPT Colorimetric
- CAT No. 2260-0
- Lot No. 26051
- Expriry: 4/18
- Manufactured: 04/27/15
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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