Recall Z-0933-2017
Sterling Diagnostics, Inc. · initiated July 20, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Serum Iron/IBC (Colorimetric), CAT No. 2200-O, Lot No. 20051, Expriry: 5/18, Manufactured: 05/11/15
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.
FDA-determined cause: Process change control
Action taken
Sterling Diagnostics, Inc. initiated their voluntary recall on 07/20/2016 by calling customers by phone to determine what kits remianed at customers' and compare withthe firm's sales records. Sterling Diagnostics followed up by sending a letter to each customer, and instructed them to take note of the corrected expiration dates for the dignostic kits, apply the revised dates to the kits in their possession, and return a customer acknowledgement to the Office Manager Luz Santa Maria at Sterling Diagnostics, Inc. at 36645 Metro Court, Sterling Heights, MI 48312. Customers with questions can call 586-979-2141.
Details
- Recall number
- Z-0933-2017
- Initiated
- July 20, 2016
- Posted by FDA
- December 29, 2016
- Terminated
- March 22, 2017
- Product code
- JIY – Photometric Method, Iron (Non-Heme)
- Quantity
- 51
- Distribution
- Domestic: MI Foreign: Phillipines VA/DOD: None
- Recalling firm
- Sterling Diagnostics, Inc., Sterling Heights, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0929-2017 Class III | Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0930-2017 Class III | Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0931-2017 Class III | Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0932-2017 Class III | Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0934-2017 Class III | Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0935-2017 Class III | Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0936-2017 Class III | Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0937-2017 Class III | Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |