Recall Z-0935-2017— Sterling Diagnostics, Inc.
Class III · Terminated
Class III FDA medical device recall by Sterling Diagnostics, Inc., initiated 2016-07-20, terminated 2017-03-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Sterling Diagnostics, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-07-20
- Terminated
- 2017-03-22
- Firm location
- Sterling Heights, MI, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.