CD8 — Class II medical device recall Z-1000-2015
Terminated recall by BD Biosciences, Systems & Reagents, reported 2015-01-28, distributed nationwide. One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect pat
| Recall number | Z-1000-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD Biosciences, Systems & Reagents, San Jose, CA, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-01-20 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2016-02-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, GT, IN, JP, MY, NZ, TH |
| Quantity | 165 units |
| Lot numbers | 4220622 |
| Model numbers | 340046 |
| Expiration dates | 2016-04-30 |
Product
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
Reason for recall
One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
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-1000-2015. 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.