1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack — Class II medical device recall Z-1700-2016
Terminated recall by Ortho-Clinical Diagnostics, reported 2016-06-01, distributed nationwide. When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range fo
| Recall number | Z-1700-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2016-02-18 |
| Classified | 2016-05-20 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2018-05-30 |
| Distributed | Nationwide (US) |
| Quantity | 14,780 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10758750002320, 10758750002337, 20758750002327, 20758750002334 |
| Lot numbers | 1410, 1420, 1430, 1440, 1450, 1460, 1470, 1480 |
| Expiration dates | 2016-06-17, 2016-08-15, 2016-08-17, 2016-09-30 |
Product
1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.
Reason for recall
When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).
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-1700-2016. 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.