The spare component Anti-HBs Cutoff Calibrator — Class III medical device recall Z-1840-2015
Terminated recall by Bio-Rad Laboratories, Inc., reported 2015-07-01, distributed in AZ, CA, ID, MO, NH. The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date
| Recall number | Z-1840-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Redmond, WA, United States |
| Recall initiated | 2015-05-13 |
| Classified | 2015-06-25 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2015-11-05 |
| Distributed | AZ, CA, ID, MO, NH |
| Quantity | 20 vials |
| Reason classes | labeling |
| Lot numbers | 11130382 |
| Model numbers | 26154 |
| Expiration dates | 2016-04-30 |
Product
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
Reason for recall
The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration date of 2016-04-30 printed on label in error.
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-1840-2015. 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.