Sterling Diagnostics — Class III medical device recall Z-0930-2017
Terminated recall by Sterling Diagnostics, Inc., reported 2017-01-04. Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of t
| Recall number | Z-0930-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sterling Diagnostics, Inc., Sterling Heights, MI, United States |
| Recall initiated | 2016-07-20 |
| Classified | 2016-12-29 |
| Reported by FDA | 2017-01-04 |
| Terminated | 2017-03-22 |
| Quantity | 245 |
| Lot numbers | 15051 |
| Model numbers | 2150-P |
Product
Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0930-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.