FDA Device recall Z-0937-2017
Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes
- FDA Device
- Class III
- terminated
- Published 2017-01-04
On 2017-01-04 the FDA classified a Class III recall of Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes by Sterling Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0937-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-07-20 |
| Published | 2017-01-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sterling Diagnostics |
| Distribution | MI, VA |
Product
Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) 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.
Identifiers
| code_info | Urea Nitrogen/Color BUN, CAT No. 2305-O , Lot No. 30551, Expriry: 7/18, Manufactured: 07/21/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0937-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.