Albumin BCP Product Usage: ALBP is an in vitro test used for the… — Class II medical device recall Z-1194-2019
Terminated recall by Roche Diagnostics Corporation, reported 2019-04-24, distributed nationwide. The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated p
| Recall number | Z-1194-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2019-03-18 |
| Classified | 2019-04-18 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 774 |
| Lot numbers | 35651401 |
| Model numbers | 05975573190 |
Product
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Reason for recall
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
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-1194-2019. 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.