FDA Device recall Z-1814-2012
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
- FDA Device
- Class III
- terminated
- Published 2012-06-27
On 2012-06-27 the FDA classified a Class III recall of Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 by Tripath Imaging, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1814-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-03-22 |
| Published | 2012-06-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tripath Imaging |
| Distribution | n/a |
Product
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Reason
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
Identifiers
| code_info | 100903ru, 100924rr, 101022sc, 110114sh, 110225ru |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1814-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.