PrepStain Installation Kit — Class III medical device recall Z-1813-2012
Terminated recall by Tripath Imaging, Inc., reported 2012-06-27. The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. T
| Recall number | Z-1813-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tripath Imaging, Inc., Burlington, NC, United States |
| Recall initiated | 2012-03-22 |
| Classified | 2012-06-15 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2012-12-03 |
| Quantity | 46,112,784 for |
| Reason classes | packaging |
| Model numbers | 490528 |
Product
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
Reason for recall
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
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-1813-2012. 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.