FDA Device recall Z-0933-2017
Sterling Diagnostics, Inc
- FDA Device
- Class III
- terminated
- Published 2017-01-04
On 2017-01-04 the FDA classified a Class III recall of Sterling Diagnostics, Inc 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-0933-2017 |
| 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. 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.
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 | Serum Iron/IBC (Colorimetric), CAT No. 2200-O, Lot No. 20051, Expriry: 5/18, Manufactured: 05/11/15 |
|---|
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-0933-2017%22
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