Sterling Diagnostics Serum Iron/IBC Diagnostic Kits Recalled for Expiration Date Issues
Sterling Diagnostics is recalling Serum Iron/IBC diagnostic kits because previously extended expiration dates were rescinded.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. The issue is administrative (rescinded expiration dates) rather than a physical defect or contamination.
Plain-English summary
Sterling Diagnostics, Inc. is recalling 51 units of Serum Iron/IBC (Colorimetric) diagnostic kits. The recall was initiated on July 20, 2016, due to the rescission of previously extended expiration dates for the kits.
The affected product is identified by Catalog No. 2200-O, Lot No. 20051, with an expiration date of 5/18 and a manufacture date of 05/11/15. The kits are intended for in vitro diagnostic use in the quantitative determination of analytes.
Distribution was limited to domestic locations in Michigan and foreign locations in the Philippines. No specific instructions for consumers are provided in the source text, but the recall is driven by administrative changes to the product's expiration status.
The recalled product
- Product
- Sterling Diagnostics, Inc. Serum Iron/IBC (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)
- Serum Iron/IBC (Colorimetric)
- CAT No. 2200-O
- Lot No. 20051
- Expriry: 5/18
- Manufactured: 05/11/15
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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