Recall Z-0936-2017 ยท CDL Berthelot Indophenol, Urea Nitrogen
Sterling Diagnostics, Inc.
Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
| Date | Dec 29, 2016 (initiated Jul 20, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Process change control |
| Action | 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 ca |
| Quantity | 131 |
| Distribution | Domestic: MI Foreign: Phillipines VA/DOD: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET Sterling Diagnostics, Inc., Feb 6, 1986 |