FDAFDA · Food and drugs·Recall number Z-0931-2017
Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Published January 4, 2017 · Recall initiated: July 20, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Sterling Diagnostics, Inc.
- Distributor
- Domestic: MI Foreign: Phillipines VA/DOD: None
- Lot
- Creatinine/Endpoint [Modified Heinegard-Tiderstrom], CAT No. 2167-O, Lot No. 16751, Expriry: 5/18, Manufactured: 06/02/15
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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